Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506779
Status:
TERMINATED
Last Update Posted:
2020-11-18
First Post:
2007-07-23
Brief Title:
GleevecTaxol for Patients With Uterine Papillary Serous Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study of GleevecTaxol in Patients With Newly Diagnosed Stage IIIC or IV or Recurrent Any Stage Uterine Papillary Serous Carcinoma UPSC
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study was terminated early due to poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
To determine the maximum tolerated dose MTD of imatinib mesylate in combination with fixed dose paclitaxel in patients with stage IIIC IV or recurrent uterine papillary serous carcinoma
To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in this cohort of patients
To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage IIIC IV or recurrent uterine papillary serous carcinoma whose tumor expresses either c-Kit PDGFR or abl
To determine the maximum tolerated dose MTD of imatinib mesylate in combination with fixed dose paclitaxel in patients with stage IIIC IV or recurrent uterine papillary serous carcinoma
To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in this cohort of patients
To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage IIIC IV or recurrent uterine papillary serous carcinoma whose tumor expresses either c-Kit PDGFR or abl
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01549 | REGISTRY | NCI CTRP | None |