Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

In brief

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth

Key facts

Study ID

NCT00036751

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2002-04-01

Last updated by the study team

2013-01-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma
• No mixed Mullerian tumors
• No borderline ovarian tumors
• Stage III or IV disease at time of diagnosis by surgical staging
• Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry
• Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially
• Measurable disease
• Performance status - Zubrod 0-1
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9 g/dL (transfusion allowed)
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
• At least 28 days since prior biologic therapy
• No concurrent anticancer biologic therapy
• No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
• At least 28 days since prior chemotherapy
• No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy
• Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen

Where it is running

• Southwest Oncology Group (SWOG) Research Base — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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