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Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin

Inclusion Criteria:

- Patients at least 18 years of age.

- Histologically documented diagnosis of epithelial carcinoma arising in the ovary,
fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must
have received initial cytoreductive surgery and chemotherapy with at least one
platinum based chemotherapy regimen.

*Eligible platinum resistant patients will have failed no more than two additional
non platinum cytotoxic regimens for their persistent or recurrent disease.

- Measurable disease.

- Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .

- Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper
limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.0 x
10E9/L, platelets > 100 x 10E9/L.

- Written, voluntary informed consent.

Exclusion Criteria:

- Patient has received any other anticancer treatment within 21 days of first day of
study drug dosing and shown recovery of any recent drug-induced neutropenia and

- Patient has another primary malignancy that has required active intervention within 5
years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.

- Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria (i.e., congestive heart failure, myocardial infarction within 6
months of study).

- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection).

- Patients on coumadin-derived anticoagulants.

- Patient with brain metastasis.

- Chronic liver disease, Hep B or C.

- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

- Patient received chemotherapy within 3 weeks -unless the disease is rapidly

- Patient previously received radiotherapy to at least 25 % of the bone marrow.

- Patient had a major surgery within 2 weeks prior to study entry.

- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.

- Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or
others on the list on page 33-37 of the protocol).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the Best Overall Clinical Response

Outcome Description:

This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Franco M Muggia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

October 2012

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • recurrent
  • Gleevec
  • Paclitaxel
  • Taxane
  • mullerian
  • Ovarian Neoplasms



NYU Cancer CenterNew York, New York  10016