Ovarian Cancer Clinical Trial

Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, or Ovarian Low Malignant Potential Tumor

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.

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Full Description

OBJECTIVES:

Determine the clinical activity of imatinib mesylate in patients with recurrent or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer or ovarian low malignant potential tumor.
Correlate the biochemical modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinases in biopsy tissue with outcome in patients treated with this drug.
Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue with response and outcome in patients treated with this drug.
Investigate the potential antiangiogenic activity of this drug in microdissected tumor cell and stromal lysates of these patients.
Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy tissue of patients treated with this drug.
Evaluate the application of surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response in these patients and/or toxicity of this drug.

OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00039585

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States
NCI - Center for Cancer Research
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00039585

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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