Clinical trial · Interventional
Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
NCT00840450CI-TRIAL-00008507terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec/Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel + Imatinib Mesylate (Gleevec)
- interventionNames
- Drug: Gleevec/Paclitaxel
Primary outcomes (1)
- measure
- the Best Overall Clinical Response
- timeFrame
- 12 weeks
- 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.
Secondary outcomes (2)
- measure
- Progression-free-tolerance
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.