Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
In brief
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
Key facts
- Study ID
- NCT00041041
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2002-06-01
- Last updated by the study team
- 2013-02-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.