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| ID | Type | Description | Link |
|---|---|---|---|
| 000237-C |
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Background:
Tumors that have spread to the lining of the abdomen from other cancers, such as cancer of the appendix, colon, or ovary, are called peritoneal carcinomatosis. In most cases, outcomes are poor. Researchers want to test a new treatment.
Objective:
To learn if the combination of oral nilotinib plus paclitaxel given by intravenous (IV) and directly into the abdomen can reduce tumors enough for people to have surgery.
Eligibility:
Adults aged 18 and older with peritoneal carcinomatosis that is too widespread for surgery.
Design:
Participants will be screened with:
Physical exam
Medical history
Blood and urine tests
Electrocardiogram
Laparoscopy. They will get general anesthesia. Small cuts will be made in their abdomen. Tissue and fluid samples will be taken.
Surveys about their health
Computed tomography (CT) scans of their torso
Participants will have up to 4 more laparoscopies. During the first procedure, a port will be placed under the skin of their abdomen (an intraperitoneal (IP) port). It will be attached to a catheter that is placed in their abdomen.
Participants will get treatment in 3-week cycles, for 3 or 6 cycles. They will take nilotinib by mouth twice daily. They will get paclitaxel by IP port (once per cycle) and by IV (twice per cycle). After cycles 3 and 6, they will have a laparoscopy and CT scans. Then they may take nilotinib and get IV paclitaxel for up to 1 year.
At study visits, participants will repeat some screening tests.
About 6 weeks after treatment ends and then every 3 months for 3 years, participants will have follow-up visits at National Institutes of Health (NIH) or with their local doctor.
Background:
Objective:
-To evaluate efficacy of bidirectional chemotherapy using intraperitoneal and intravenous paclitaxel and oral nilotinib by calculating the rate of downstaging of peritoneal disease burden to become resectable, based on Peritoneal Carcinomatosis Index (PCI)
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/ Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy | Experimental | Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with oral nilotinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel: Intraperitoneal (IP) paclitaxel will be dosed at 60 mg/m^2 to be infused over 1 hour on Day 1 of each 3-week cycle; participants with unresectable, but stable or responding disease after C1 through C3 will dose increase IP paclitaxel to 80 mg/m2 for Cycles 4-6. Intravenous (IV) paclitaxel will be infused over 1 hour on Day 2 of the first week of Cycle 1, followed by Day 1 of the subsequent treatment weeks; IV paclitaxel will be dosed at 60 mg/m2 for Week 1 of Cycle 1 and, if tolerated, at 80 mg/m2 for subsequent treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval | We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned. Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is < 4 points higher or lower compared to PCI score at lap #2. Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) has at least 4 points increase in PCI. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. To document PCI scoring for each participant, the rubric will be completed following each laparoscopy. The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis. | Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days |
| Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval. | The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib). | Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval. | Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
In order to be eligible to participate in this study, an individual must meet all of the following criteria.
Histological confirmation of peritoneal carcinomatosis from colorectal, appendiceal, small bowel, gastric, cholangiocarcinoma, breast, ovarian, or other gynecologic (i.e., endometrial, fallopian tube, primary peritoneal, cervical) primary by the Laboratory of Pathology, national Cancer Institute (NCI).
Participants must have been treated with at least one line of approved systemic chemotherapy, with demonstrated resistance or lack of response
Measurable or evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. criteria and/or by Peritoneal Carcinomatosis Index (PCI)
Participants must be assessed to not be candidates for cytoreductive surgery, with laparoscopically assessed Peritoneal Cancer Index (PCI) score thresholds as indicated below:
--Primary Histology PCI Cutoff for Eligibility
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 60%).
Participants must have adequate organ and marrow function as defined below:
Nursing (including breastfeeding) participant must agree to discontinue nursing.
Individuals of child-bearing potential (IOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 90 days after last study treatment. Should an individual of child-bearing potential suspect to be pregnant while participating in this study, the individual should inform the treating physician immediately.
Ability of participant to understand and the willingness to sign a written informed consent document.
Participants must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study.
Note: Exclusion of participants who have undergone major abdominal surgery within the last 12 weeks prior to start of study treatment is to allow for scar tissue formation from that surgery to stabilize. Participant ECOG performance status will be checked to account for prolonged or difficult recoveries from other types of major surgery that would appropriately influence eligibility assessment.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Blakely, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated | Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m^2 then 80mg/m^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m^2 then Cycles 4-6 80mg/m^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2024 |
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| Nilotinib | Drug | Oral nilotinib will be dosed at 300 mg twice daily. Nilotinib will be administered continually from the loading dose (Day -4) leading up to laparoscopy #2 onward. |
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| ECG | Diagnostic Test | Screening, Week -1, Cycle 1 and 4 Day 1 (±3 days at start of cycle), Cycle 2 and 5 Day 1 (±3 days at start of cycle), Cycle 3 and 6 Day 1 (±3 days at start of cycle) and 4-8 Weeks post-therapy (±2 weeks). |
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| CT Scan CAP | Diagnostic Test | Screening, Cycle 3 and 6 Day 1, Week 6, and every 3 months (± 2 weeks) for up to 3 years total. |
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| Laparoscopy | Procedure | Screening, Day 0, Week -1, and Cycle 3 and 6, Week 3. |
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| Peritoneal biopsies + ascites washings | Procedure | Screening (intra-op), Week -1, Day 0 (intra-op), and on treatment (± 1 day), Cycle 3 and 6, Week 3 (intra-op). Biopsy only done if deemed eligible per laparoscopy (only performed during laparoscopy). |
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| Percent Probability of Peritoneal Progression-free Survival (pPFS) | Percent pPFS will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology. PFS is defined as the duration of time from the start of the treatment until time of peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, or death, whichever comes first, and after completion of therapy. Response was assessed by the Peritoneal Carcinomatosis Index (PCI) and the Response Evaluation Criteria in Solid Tumors (RECIST). Disease relapse is CR is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Disease progression is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progressions. The Kaplan-Meier method calculates a survival function S(t), which represents the probability of "surviving" (remaining event-free) beyond time t. It is not calculated directly as a percentage. | From baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy up to a percent probability of PFS at 12 months |
| Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Day-4 through completion of surveillance post-treatment, up to 2 years. |
| Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument | Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate | Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment |
| Median Peritoneal Progression-free Survival (pPFS) | Kaplan-Meier method will be used to evaluate peritoneal progression-free survival (pPFS). Median peritoneal progression-free survival (pPFS) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and will be reported along with a 95% two-sided confidence interval. Progressive Disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. The appearance of one or more new lesions is also considered progression. | Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months |
| Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval | The percentage of participants with a clinicopathologic response will be reported for all participants along with a 95% confidence interval. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. | Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days |
| Median Overall Survival (OS) | Kaplan-Meier method will be used to evaluate median overall OS and will be reported with a 95% confidence interval. Overall survival (OS) is defined as the time from the start of the treatment until time of death from any cause, for up to 3 years after completion of therapy, assessed every 3 months (±2 weeks). | From time of initiation of study treatment to death or last follow-up, a median of 5.60 months |
| Percentage of Participants Who Become Resectable by Individual Histologies | The percentage of participants who become resectable will be evaluated by individual histologies. | Baseline, at peritoneal disease relapse from complete response (CR) or peritoneal disease progression, and after completion of therapy, up to 2 years |
| Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Outcomes from QOL using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire comparing results before to after treatment: physical and mental health-related quality of life will be reported. The EQ-5D-5L questionnaire assesses participants' physical and mental health-related quality of life (QOL). Questionnaires will be provided to the participants in an electronic application-based format to be filled out at baseline, and immediately prior to Cycles 3 and 6 and in follow-up. An index score of 100 is considered perfect health with no problems in any dimension. A score of 0.0 would be dead. A single value (average) was calculated for "during treatment immediately prior to Cycles 3 and Cycle 6". | Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days |
| Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval | Clinicopathologic response by PCI is reported with a 95% confidence interval. Complete Response (CR) is PCI ≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. | Baseline, every 9 weeks during treatment, and then every 3 months for 2 years |
| Day-4 through completion of surveillance post-treatment, up to 2 years |
| FG001 | Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated | Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m^2 then 80mg/m^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m^2 then Cycles 4-6 80mg/m^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment. |
| FG002 | Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated | Participants were enrolled, were not assigned to an Arm/Cohort and were not treated. |
| De-escalated Nilotinib Dose |
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| De-escalated Intravenous (IV) Paclitaxel Dose |
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| De-escalated Intraperitoneal (IP) Paclitaxel Dose |
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| NOT COMPLETED |
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We report all participants enrolled to the study. As such, baseline data collected for participants enrolled, not assigned to an Arm/Cohort and not treated are reported here.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated | Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m^2 then 80mg/m^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m^2 then Cycles 4-6 80mg/m^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment. |
| BG001 | Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated | Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m^2 then 80mg/m^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m^2 then Cycles 4-6 80mg/m^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment. |
| BG002 | Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated | Participants were enrolled, were not assigned to an Arm/Cohort, and were not treated. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval | We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned. Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is < 4 points higher or lower compared to PCI score at lap #2. Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) has at least 4 points increase in PCI. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. To document PCI scoring for each participant, the rubric will be completed following each laparoscopy. The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis. | 7/21 participants were analyzed because 12 participants were not treated and 2 declined further treatment. When the study was designed, we anticipated having some participants reach a point where their disease is resectable. | Posted | Number | 95% Confidence Interval | proportion of participants | Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days |
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| Primary | Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval. | The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib). | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Median | 95% Confidence Interval | Months | Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days |
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| Secondary | Percent Probability of Peritoneal Progression-free Survival (pPFS) | Percent pPFS will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology. PFS is defined as the duration of time from the start of the treatment until time of peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, or death, whichever comes first, and after completion of therapy. Response was assessed by the Peritoneal Carcinomatosis Index (PCI) and the Response Evaluation Criteria in Solid Tumors (RECIST). Disease relapse is CR is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Disease progression is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progressions. The Kaplan-Meier method calculates a survival function S(t), which represents the probability of "surviving" (remaining event-free) beyond time t. It is not calculated directly as a percentage. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. In this table, there are 0 participants analyzed in the 1st, 2nd, 3rd, and 4th groups/columns because there were no Colorectal participants in those groups. That is the case for the other histologies as well. | Posted | Number | 95% Confidence Interval | percent probability | From baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy up to a percent probability of PFS at 12 months |
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| Secondary | Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Number | toxicities | Day-4 through completion of surveillance post-treatment, up to 2 years. |
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| Secondary | Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument | Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate | 6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group "Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected). | Posted | Median | Full Range | Score on a scale | Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment |
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| Secondary | Median Peritoneal Progression-free Survival (pPFS) | Kaplan-Meier method will be used to evaluate peritoneal progression-free survival (pPFS). Median peritoneal progression-free survival (pPFS) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and will be reported along with a 95% two-sided confidence interval. Progressive Disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. The appearance of one or more new lesions is also considered progression. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months |
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| Secondary | Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval | The percentage of participants with a clinicopathologic response will be reported for all participants along with a 95% confidence interval. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment, for the duration of the study (27 months, 14 days). | Posted | Number | 95% Confidence Interval | percentage of participants | Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days |
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| Secondary | Median Overall Survival (OS) | Kaplan-Meier method will be used to evaluate median overall OS and will be reported with a 95% confidence interval. Overall survival (OS) is defined as the time from the start of the treatment until time of death from any cause, for up to 3 years after completion of therapy, assessed every 3 months (±2 weeks). | 6/21 participants were analyzed because one participant was alive at last contact, including at study closure,12 were not treated and 2 refused further treatment. | Posted | Median | 95% Confidence Interval | Months | From time of initiation of study treatment to death or last follow-up, a median of 5.60 months |
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| Secondary | Percentage of Participants Who Become Resectable by Individual Histologies | The percentage of participants who become resectable will be evaluated by individual histologies. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. When the study was designed, we anticipated having some participants reach a point where their disease is resectable. | Posted | Number | percentage of participants | Baseline, at peritoneal disease relapse from complete response (CR) or peritoneal disease progression, and after completion of therapy, up to 2 years |
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| Secondary | Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Outcomes from QOL using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire comparing results before to after treatment: physical and mental health-related quality of life will be reported. The EQ-5D-5L questionnaire assesses participants' physical and mental health-related quality of life (QOL). Questionnaires will be provided to the participants in an electronic application-based format to be filled out at baseline, and immediately prior to Cycles 3 and 6 and in follow-up. An index score of 100 is considered perfect health with no problems in any dimension. A score of 0.0 would be dead. A single value (average) was calculated for "during treatment immediately prior to Cycles 3 and Cycle 6". | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. 0 analyzed in the first Arm/Group "During" and "After Treatment" because participants were off study, non-English speaking and/or failed to complete the QOL. 0 participants were analyzed in the last 2 Arm/Groups "After Treatment" due to death. | Posted | Median | Full Range | Score on a scale | Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days |
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| Secondary | Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval | Clinicopathologic response by PCI is reported with a 95% confidence interval. Complete Response (CR) is PCI ≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, every 9 weeks during treatment, and then every 3 months for 2 years |
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| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. | Posted | Count of Participants | Participants | Day-4 through completion of surveillance post-treatment, up to 2 years |
|
All-Cause Mortality was monitored/assessed an average of 5.60 months. Adverse Events were monitored/assessed Day-4 through completion of surveillance post-treatment, up to 2 years.
"Participants Enrolled, and Assigned to an Arm/Cohort, But Not Treated", and "Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated" are excluded in the table because only treated participants were assessed for death and adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID). | 4 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). | 1 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). | 1 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Blakely | National Cancer Institute | 240-760-7647 | andrew.blakely@nih.gov |
| Aug 7, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2024 | Aug 7, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D010534 | Peritoneal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001063 | Appendiceal Neoplasms |
| D018281 | Cholangiocarcinoma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002430 | Cecal Neoplasms |
| D002429 | Cecal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C498826 | nilotinib |
| D004562 | Electrocardiography |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Every 9 weeks during treatment through study completion, final assessment reported |
|
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 |
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
| OG001 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel. |
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel.
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG000 |
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 |
Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID). |
| OG001 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel. |
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG001 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel. |
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG001 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m^2 of intravenous (IV) Paclitaxel. |
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
|
|
| OG002 | Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD). |
| OG003 | Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD). |
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