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Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer

Intervention: Gleevec/Paclitaxel (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Franco M Muggia, MD, Principal Investigator, Affiliation: New York University School of Medicine

Summary

This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.

Clinical Details

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

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

Primary outcome: the Best Overall Clinical Response

Secondary outcome:

Progression-free-tolerance

Progression-free-survival at 12 Months

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 thrombocytopenia.

- 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

progressing.

- 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).

Locations and Contacts

NYU cancer center, New York, New York 10016, United States
Additional Information

publication for this trial

Starting date: April 2007
Last updated: November 12, 2012

Page last updated: August 23, 2015

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