Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer
Trial ID: NCT00039585
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2002-05
Sponsor: National Cancer Institute (NCI)
Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Interventions: imatinib mesylate
Locations: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; NCI - Center for Cancer Research
Countries: United States; United States
Age range: None - None
Sex: FEMALE

Summary:
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer, or ovarian low malignant potential tumor.

Eligibility criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer OR
* Histologically confirmed ovarian low malignant potential tumor with invasive recurrence
* Relapsed after and/or refractory to platinum- and taxane-based chemotherapy
* Patients in first relapse after a disease-free interval of more than 1 year are eligible
* Measurable disease outside prior radiation field
* Availability of a sentinel lesion that is adequate for core biopsy through percutaneous biopsy or simple laparoscopic means
* Patients with clinical evidence of CNS involvement (abnormal clinical examination) must have a negative CT scan with contrast or MRI of the brain
* No large volume ascites or pleural effusion

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
* Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion)
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No myocardial infarction or unstable dysrhythmia within the past 6 months
* No congestive heart failure (CHF), including CHF that may be compensated with furosemide

Other:

* No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study completion
* Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the discretion of the principal investigator (PI)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior signal transduction therapy

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin)

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy

Surgery:

* See Disease Characteristics

Other:

* Recovered from prior anticancer therapy
* At least 1 week since prior antibiotics
* No more than 4 prior anticancer regimens
* No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin
* No concurrent therapeutic warfarin

  * Patients who can be safely converted over to low molecular weight heparin are eligible
* No concurrent grapefruit or grapefruit juice
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent alternative or complementary therapies or over-the-counter agents unless approved by the PI
* Concurrent medications that may alter the metabolism of imatinib mesylate and lead to potential toxicity are allowed at the discretion of the PI

Outcomes:
Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks