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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01549 | Registry Identifier | NCI CTRP |
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the study was terminated early due to poor enrollment
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Objectives:
Before possible study participants can receive treatment with imatinib mesylate and paclitaxel, their tumor tissue that was previously collected (at the surgery to diagnose your tumor) will be tested for the following three biomarkers: c-Kit, PDGFR-B, and Abl. Those participants who have at least one positive biomarker will be eligible for treatment on this study.
Paclitaxel is a chemotherapy drug used in the treatment of ovarian cancer. Imatinib mesylate is a medication that blocks several proteins that are important in the development of cancer.
Before treatment starts, you will have a complete physical exam, routine blood tests (about 2-3 teaspoons), an electrocardiogram (ECG--a test to measure the electrical activity of the heart). You will have an echocardiogram (an ultrasound test used to visualize the structures of the heart), a chest x-ray, and a CT scan or MRI of the abdomen and pelvis. Women who are able to have children must have a negative blood pregnancy test.
Routine blood tests (about 2 teaspoons) will be done weekly during treatment, and before each course of therapy, which is every 3 weeks. A complete checkup including evaluation of side effects, will also be done before each course of therapy and at the end of therapy (3 weeks after treatment ends).
There are two phases to this study, Phase I and Phase II. If you are assigned to Phase 1, you will receive treatment with imatinib mesylate and paclitaxel. Phase 1 will study 3 different doses of imatinib mesylate in combination with a fixed dose of paclitaxel. The Phase I part of the study will help researchers learn the most effective dose of imatinib mesylate to be used in combination with paclitaxel. All participants in Phase 1 will receive one of three doses of imatinib mesylate to be given with a standard dose of paclitaxel. You will be assigned to a specific dose level based on the number of participants treated at the time of your enrollment.
The Phase II portion of the study will begin only after the most effective dose of imatinib mesylate has been determined.
If you are assigned to Phase II, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive treatment with paclitaxel only (every 21 days). Participants in the second group will receive treatment with paclitaxel (every 21 days) along with imatinib mesylate (every day). The dose level of imatinib mesylate that you receive will be the same as the dose used during Phase I. The computer-generated assignment will favor the treatment group which is more effective. For example, if the combination of paclitaxel and imatinib mesylate is more effective than paclitaxel alone, then more patients will be selected to receive the combination therapy.
You will receive paclitaxel by vein over 3 hours every 21 days. Those participants who are assigned treatment with both paclitaxel and imatinib mesylate will begin taking imatinib mesylate the day after the first dose of paclitaxel. A single dose of imatinib mesylate will be taken by mouth every day.
Evaluation of tumor response (for participants who already have the disease) will be determined by CT scan or MRI and chest x-ray (patients with chest disease). These scans will be taken after Courses 2 and 4 , then after every 3 courses until the therapy is finished, and once more at the end of therapy. Patients who show no signs of the disease will be given a total of up to 6 courses. Patients who have the disease may continue treatment until the disease gets worse. You will be taken off study if the disease gets worse or intolerable side effects occur. If you are removed from the study, you will be asked to have a follow-up CT scan or MRI and chest x-ray to evaluate the tumor.
THIS IS AN INVESTIGATIONAL STUDY. Paclitaxel is commercially available and approved for use in the treatment of ovarian cancer. Gleevec® is also commercially available and approved for use in the treatment of certain types of adult leukemias and stomach cancers. The combination of paclitaxel and imatinib mesylate is still investigational and has been approved for use in research only.
At least 51 and as many as 65 participants will take part in this study. All participants will be enrolled and treated at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Paclitaxel + Imatinib Mesylate | Experimental | Phase I MTD using oral dose Imatinib Mesylate escalation 400, 500, 600 mg daily; Paclitaxel 175 mg/m^2 every 21 days |
|
| Phase II: Paclitaxel Alone or Pacliataxel + Imatinib Mesylate | Experimental | Intended randomization of Paclitaxel alone or Paclitaxel + Imatinib Mesylate; the study was terminated early due to poor enrollment and all patients are no longer being treated or followed. Single treatment arm MTD using oral dose Imatinib Mesylate escalation = 500 mg daily; Paclitaxel 175 mg/m^2 every 21 days Phase II, (Arm 1) = Paclitaxel 175 mg/m^2 every 21 days Phase II, (Arm 2) Paclitaxel 175 mg/m^2 every 21 days+ Imatinib Mesylate MTD using oral dose Imatinib Mesylate escalation = 500 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate | Drug | Phase I = Maximum tolerated dose (MTD) derived from dose escalation of 400, 500, 600 mg by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Maximum Tolerated Dose (MTD) of Oral Imatinib Mesylate in Combination with Fixed Dose Paclitaxel where MTD of Imatinib Mesylate (mg/m^2 daily) to be determined with conventional 3+3 design, MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose limiting toxicity (DLT). Study utilizes Common Terminology for Adverse Events Criteria (CTCAE) version 3.0 for adverse event reporting. Following cohorts of 3 at lower dose levels until 1 of 3 patients experiences DLT; if 1 of 3 patients experiences DLT at dose level, enter 3 additional patients at dose level, if only 1 of 6 patients experiences DLT at dose level, proceed to next higher dose level with cohort of 3; If 2 of 3 or 3 of 6 patients experience DLT, MTD has exceeded. Once DLT exceeded, treat another 3 patients at previous dose if there were only 3 patients treated at that dose level. MTD is highest dose level in which treated 6 patients with at most 2 experiencing the DLT. | Evaluated at 3 weeks (one cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | Complete Response (CR): Disappearance lesions, no evidence new lesions documented by 2 disease assessments> 4 weeks apart. Partial Response (PR):>30% decrease in sum longest dimensions (LD) all target measurable lesions reference baseline sum of LD; No progression non-target lesions & no new lesions; Documentation by 2 disease assessments >4 weeks apart; Progressive Disease (PD) (ANY of following): >20% increase in sum LD of target lesions reference smallest sum LD or appearance of new lesions within 8 weeks of study entry; Unequivocal progression on existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, within 8 weeks of study entry also considered increasing disease. Death due to disease without prior objective documentation of progression; Global deterioration in health attributable to disease requiring change in therapy without objective evidence of progression. Stable disease: Any condition not meeting above criteria. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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The study was terminated early due to poor enrollment .
Recruitment Period: December 29, 2003 to October 27, 2009. Recruitment was done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Imatinib Mesylate 400 mg | Cohort One = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec). Phase I Maximum Tolerated Dose (MTD) to be determined from escalating doses in subsequent cohorts: 400 (this arm, Cohort One), 500 (Cohort Two) or 600 mg (Cohort Three) orally daily. |
| FG001 | Phase I: Imatinib Mesylate 500 mg | Cohort Two = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily |
| FG002 | Phase I: Imatinib Mesylate 600 mg | Cohort Three = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily |
| FG003 | Phase II: Imatinib Mesylate MTD 500 mg | Phase II, Cohort 4 = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Paclitaxel + Imatinib Mesylate | Phase I = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec) 400, 500 or 600 mg orally daily |
| BG001 | Phase II: Paclitaxel + Imatinib Mesylate MTD 500 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Maximum Tolerated Dose (MTD) of Oral Imatinib Mesylate in Combination with Fixed Dose Paclitaxel where MTD of Imatinib Mesylate (mg/m^2 daily) to be determined with conventional 3+3 design, MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose limiting toxicity (DLT). Study utilizes Common Terminology for Adverse Events Criteria (CTCAE) version 3.0 for adverse event reporting. Following cohorts of 3 at lower dose levels until 1 of 3 patients experiences DLT; if 1 of 3 patients experiences DLT at dose level, enter 3 additional patients at dose level, if only 1 of 6 patients experiences DLT at dose level, proceed to next higher dose level with cohort of 3; If 2 of 3 or 3 of 6 patients experience DLT, MTD has exceeded. Once DLT exceeded, treat another 3 patients at previous dose if there were only 3 patients treated at that dose level. MTD is highest dose level in which treated 6 patients with at most 2 experiencing the DLT. | One participant of 12 registered withdrew prior to receiving treatment. | Posted | Number | participants | Evaluated at 3 weeks (one cycle) |
Adverse Event collection with each 3 week cycle, up to 6 cycles (18 weeks).
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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 | Phase I: Imatinib Mesylate 400mg | Cohort One = Paclitaxel (Taxol) 175 mg/m^2 intravenous (IV) every 21 days + Imatinib Mesylate (Gleevec). Phase I Maximum Tolerated Dose (MTD) to be determined from escalating doses in subsequent cohorts: 400 (this arm, Cohort One), 500 (Cohort Two) or 600 mg (Cohort Three) orally daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever w/o Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Gershenson, MD | University of Texas (UT) MD Anderson Cancer Center | 713-745-2565 | DGershen@mdanderson.org |
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| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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|
| Paclitaxel | Drug | 175 mg/m^2 by vein over 3 Hours every 21 Days |
|
|
| 6 weeks to 18 weeks; Best response achieved since study entry where measurable disease defined as => 1 lesion accurately measured in at least 1 dimension (longest dimension to be recorded) |
| Time to Tumor Progression | Efficacy of Gleevec and Taxol in Participants defined by tumor progression for participants with measurable disease or recurrent non-measurable disease. Time to tumor progression defined as the time from date of initial treatment to first objective documentation of disease progression. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). After two cycles (6 weeks), participants will undergo clinical and radiographic (participants with measurable disease) tumor restaging or confirmation recurrent non-measurable disease. Evaluation of tumor response (for participants who already have the disease) determined by CT scan or MRI and chest x-ray (participants with chest disease). | Evaluation at at 6 weeks, tumor restaging continued up to 6 cycles (18 weeks) or until disease progression, whichever comes first |
| Adverse Event |
|
Phase II = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Imatinib Mesylate 400 mg | Cohort One = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 400 mg orally daily |
| OG001 | Imatinib Mesylate 500 mg | Cohort Two = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily |
| OG002 | Imatinib Mesylate 600 mg | Cohort Three = Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily |
|
|
| Secondary | Number of Participants With Complete Response | Complete Response (CR): Disappearance lesions, no evidence new lesions documented by 2 disease assessments> 4 weeks apart. Partial Response (PR):>30% decrease in sum longest dimensions (LD) all target measurable lesions reference baseline sum of LD; No progression non-target lesions & no new lesions; Documentation by 2 disease assessments >4 weeks apart; Progressive Disease (PD) (ANY of following): >20% increase in sum LD of target lesions reference smallest sum LD or appearance of new lesions within 8 weeks of study entry; Unequivocal progression on existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, within 8 weeks of study entry also considered increasing disease. Death due to disease without prior objective documentation of progression; Global deterioration in health attributable to disease requiring change in therapy without objective evidence of progression. Stable disease: Any condition not meeting above criteria. | Posted | Number | participants | 6 weeks to 18 weeks; Best response achieved since study entry where measurable disease defined as => 1 lesion accurately measured in at least 1 dimension (longest dimension to be recorded) |
|
|
|
| Secondary | Time to Tumor Progression | Efficacy of Gleevec and Taxol in Participants defined by tumor progression for participants with measurable disease or recurrent non-measurable disease. Time to tumor progression defined as the time from date of initial treatment to first objective documentation of disease progression. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). After two cycles (6 weeks), participants will undergo clinical and radiographic (participants with measurable disease) tumor restaging or confirmation recurrent non-measurable disease. Evaluation of tumor response (for participants who already have the disease) determined by CT scan or MRI and chest x-ray (participants with chest disease). | Due to poor enrollment, the study was terminated early and no data collected for the Time to tumor progression outcome measure. | Posted | Evaluation at at 6 weeks, tumor restaging continued up to 6 cycles (18 weeks) or until disease progression, whichever comes first |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Phase II: Imatinib Mesylate 500 mg | Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 500 mg orally daily | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Phase 1: Imatinib Mesylate 600 mg | Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate 600 mg orally daily | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Phase II: Imatinib Mesylate MTD 500 mg | Paclitaxel 175 mg/m^2 IV every 21 days + Imatinib Mesylate at MTD 500 mg orally | 0 | 5 | 0 | 5 | 5 | 5 |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash - desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration - anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema - facial | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - pleura | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| SGOT - elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| SGPT - elevated | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |