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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-0412 | |||
| SANOFI - AVENTIS-NU0412 | |||
| NU-948-006 | |||
| STU00006778 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for at least 2 courses in the absence of disease progression, symptomatic tumor progression, or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacogenomic correlative studies. Plasma concentrations of docetaxel are analyzed by reverse-phase high performance liquid chromatography and tandem mass spectrometry. Polymorphisms in CYP3A4/5, MDR, and other genes are analyzed by PCR.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 73 patients (30 for phase I and 43 for phase II) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 |
|
| Cohort 2a | Experimental | Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 |
|
| Cohort 3a | Experimental | Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 |
|
| Cohort 4a | Experimental | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 |
|
| Cohort 5a | Experimental | Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I) | The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0 | After completion of 1 cycle of therapy (1 cycle = 14 days) |
| Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II) | Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease - <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | After 4 cycles of therapy (1 cycle = 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil | Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT. Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of >75,000/ul by day 15. Grade 4 neutropenia, not recovered to count of >1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15 |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1 of the following criteria:
Unidimensionally measurable disease by CT scan or MRI
No uncontrolled brain metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8.0 g/dL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin normal
Meets 1 of the following criteria:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
No preexisting neuropathy
No concurrent uncontrolled illness or other condition that would preclude study compliance
No history of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Mulcahy, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31138725 | Derived | Rosenberg AJ, Rademaker A, Hochster HS, Ryan T, Hensing T, Shankaran V, Baddi L, Mahalingam D, Mulcahy MF, Benson AB 3rd. Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up. Oncologist. 2019 Aug;24(8):1039-e642. doi: 10.1634/theoncologist.2019-0330. Epub 2019 May 28. |
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Phase I was opened to all solid tumor cancers and phase II was opened to stomach/gastro-esophageal junction cancer only.
The study opened for accrual on March 3, 2005 and the first patient was enrolled April 20 2005. Accrual goal of approximately 50 for the phase I and phase II portion. Accrual for phase I was suspended on February 13 2006 reopened with phase II accrual on February 16, 2006. The study was closed permanently on July 23, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a | Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Registed and Started Treatment |
|
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| fluorouracil | Drug | Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. |
|
| oxaliplatin | Drug | Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
|
| After 1 cycle of therapy (1 cycle = 14 days) |
| Frequency of CYP3A4, CYP3A5, and MDR Polymorphisms and Their Impact on Docetaxel Toxicity | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
| Frequency of XRCC1 and ERCC2 Polymorphisms and Their Impact on Oxaliplatin Toxicity | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
| Frequency of DPD and TSER Polymorphisms and Their Impact on Fluorouracil Toxicity | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
| Toxicity Profile | Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatment |
| FG001 | Cohort 2a | Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| FG002 | Cohort 3a | Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| FG003 | Cohort 4a | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| FG004 | Cohort 5a | Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| FG005 | Phase II | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| Registered to Study |
|
| Started Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Reached First Response/4 Cycles |
|
|
| Treated Cycle 5 After First Response |
|
|
| Follow up Every 3 Months Until Death |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a | Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG001 | Cohort 2a | Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG002 | Cohort 3a | Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG003 | Cohort 4a | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG004 | Cohort 5a | Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG005 | Phase II | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I) | The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0 | Dose of docetaxel was escalated up through 5 cohorts. | Posted | Number | mg/m2 | After completion of 1 cycle of therapy (1 cycle = 14 days) |
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|
| ||||||||||||||||||||||||||
| Primary | Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II) | Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease - <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | One patient that was registered to phase II did not get treated on study and was therefore not evaluable. Two patients did not reach first response at 4 cycles and therefore were not evaluable. | Posted | Number | percentage of patients | After 4 cycles of therapy (1 cycle = 14 days) |
| ||||||||||||||||||||||||||||
| Secondary | Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil | Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT. Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of >75,000/ul by day 15. Grade 4 neutropenia, not recovered to count of >1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15 | 15 patients enrolled in 5 dose escalating cohorts were monitored for DLTs in the phase I part of the study. | Posted | Number | participants | After 1 cycle of therapy (1 cycle = 14 days) |
| ||||||||||||||||||||||||||||
| Secondary | Frequency of CYP3A4, CYP3A5, and MDR Polymorphisms and Their Impact on Docetaxel Toxicity | Data not collected. | Posted | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
|
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| Secondary | Frequency of XRCC1 and ERCC2 Polymorphisms and Their Impact on Oxaliplatin Toxicity | Data not collected. | Posted | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
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| Secondary | Frequency of DPD and TSER Polymorphisms and Their Impact on Fluorouracil Toxicity | Data not collected. | Posted | Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle |
|
| ||||||||||||||||||||||||||||||
| Secondary | Toxicity Profile | Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Data collected and analyzed for patients enrolled in the phase II of the study only.1 Patient did not receive treatment on study and was not evaluable. For each patient that experienced the toxicity, highest grade for that patient is recorded. Grades ranging between 1-5 were collected and are represented below. | Posted | Number | participants | Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatment |
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| Post-Hoc | Median Overall Survival (OS) | Median Overall Survival (OS) | Patients enrolled in phase II portion of the study were evaluable for OS. One patient in phase II was registered to the study but did not receive treatment and was not evaluable for OS. Two patients did not have death dates and were censored for the last known time to be living. | Posted | Median | 95% Confidence Interval | Months | From first day of treatment until death from any cause measured, assessed up to 4 years |
|
|
Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1a | Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 3 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Cohort 2a | Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 3 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Cohort 3a | Docetaxel 40 mg/m2+ oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 3 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Cohort 4a | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 3 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Cohort 5a | Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 3 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase II | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel | 41 | 43 | 11 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Resulted in death |
|
| GI bleed | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Resulted in death |
|
| Death | Social circumstances | CTCAE (3.0) | Systematic Assessment | Reason unknown |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea and vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal bleeding | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Brain metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | Found as a result of a seizure |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergy | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Transaminitis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Motor Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered taste | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine, Serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Auditory | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nose bleed | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Speech | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI Bleed | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Mulcahy (MD) | Northwestern University | 312.695.6182 | Mary.Mulcahy@nm.org |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Progressive disease |
|
| Death |
|
| Decline in performance status |
|
| 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 |
|
|
|
| OG002 | Cohort 3a | Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| OG003 | Cohort 4a | Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
| OG004 | Cohort 5a | Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2 docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration. oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|