Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
NCT00041041CI-TRIAL-00009509completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- At 6 months
- measure
- Frequency and severity of adverse effects as assessed by CTC
- timeFrame
- Up to 7 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent disease * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Tumors within a previously irradiated field considered nontarget lesions * At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required * Initial treatment may include high-dose, consolidation, or extended therapy * Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen * Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen * Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) * Performance status - GOG 0-2 (if patient has received one prior treatment regimen) * Performance status - GOG 0-1 (if patient has received two prior treatment regimens) * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation * No active infection requiring antibiotics * No greater than grade 1 sensory and motor neuropathy * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No signs or symptoms of bowel dysfunction * At least 3 weeks since prior immunologic therapy directed at the malignant tumor * No concurrent biologic therapy or immunotherapy for the malignant tumor * Recovered from prior chemotherapy * No prior noncytotoxic chemotherapy for persistent or recurrent disease * One additional cytotoxic regimen for persistent or recurrent disease allowed * No concurrent chemotherapy for the malignant tumor * At least 1 week since prior hormonal therapy directed at the malignant tumor * No concurrent therapeutic corticosteroids * No concurrent anticancer hormonal therapy * Concurrent hormone replacement therapy allowed * Recovered from prior radiotherapy * No prior radiotherapy to more than 25% of marrow-bearing areas * No concurrent anticancer radiotherapy * Recovered from recent prior surgery * At least 3 weeks since other prior therapies directed at the malignant tumor * No prior imatinib mesylate * No prior anticancer therapy that would preclude study participation * No concurrent therapeutic anticoagulation with warfarin * No other concurrent investigational drugs * No concurrent amifostine or other protective reagents
References
Publications (0)
Data not yet available
No reference posted for this study.