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

NCT ID: NCT00039585

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31

Brief 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.

Detailed 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

imatinib mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Elise C. Kohn, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Virginia Kwitkowski, MS, RN, CS, CRNP

Role:

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Countries

United States

References

Hussain M, Kotz H, Minasian L, et al.: Occurrence of ascites secondary to STI571 in ovarian cancer patients . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-880, 2003.

Reference Type: RESULT

Other Identifiers

NCI-02-C-0190

Identifier Type: -

Identifier Source: secondary_id

NCI-5672A

Identifier Type: -

Identifier Source: secondary_id

CDR0000069403

Identifier Type: -

Identifier Source: org_study_id

NCT00035646

Identifier Type: -

Identifier Source: nct_alias