Clinical Trial: Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Study of Gleevec/Taxol in Patients With Newly Diagnosed Stage IIIC or IV or Recurrent (Any Stage) Uterine Papillary Serous Carcinoma (UPSC)

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.

Detailed Summary:

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 dose
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Maximum Tolerated Dose (MTD) of Imatinib Mesylate in Combination with Fixed Dose Paclitaxel [ Time Frame: Evaulated with each 3 week cycle ]

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.


Original Primary Outcome:

Current Secondary Outcome: Efficacy of Gleevec and Taxol in Participants with Stage IIIC, IV or Recurrent Uterine Papillary Serous Carcinoma Whose Tumor Expresses Either c-KIT, PDGFR, Abl [ Time Frame: 6 weeks ]

Efficacy defined by duration of response (time to tumor progression for participants with measurable disease) and disease-free interval (duration of response for those with non-measurable disease). Response duration measured from time of response (not the beginning of treatment) until there is evidence of progressive disease. Time to treatment failure also be measured in responding patients.

Evaluation of tumor response (for participants who already have the disease) determined by CT scan or MRI and chest x-ray (patients with chest disease).



Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 23, 2007
Date Started: December 2003
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015