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

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrentovarian epithelial or primaryperitoneal cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer peritoneal cavity cancer	Drug: imatinib mesylate  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the cytostatic antitumor activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
• Determine the frequency and severity of adverse effects of this drug in these patients.
• Determine the distribution of overall and progression-free survival in patients treated with this drug.
• Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
• Determine the effects of this drug on initial performance status, platinum sensitivity, and mucinous (or clear cell) histology in these patients.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 4-15 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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)

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• GOG 0-2 (if patient has received one prior treatment regimen)
• GOG 0-1 (if patient has received two prior treatment regimens)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 3 weeks since prior immunologic therapy directed at the malignant tumor
• No concurrent biologic therapy or immunotherapy for the malignant tumor

Chemotherapy:

• See Disease Characteristics
• Recovered from prior chemotherapy
• No prior noncytotoxic chemotherapy for persistent or recurrent disease
• One additional cytotoxic regimen for persistent or recurrent disease allowed
• No concurrent chemotherapy for the malignant tumor

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at the malignant tumor
• No concurrent therapeutic corticosteroids
• No concurrent anticancer hormonal therapy
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy
• No prior radiotherapy to more than 25% of marrow-bearing areas
• No concurrent anticancer radiotherapy

Surgery:

• Recovered from recent prior surgery

Other:

• At least 3 weeks since other prior therapies directed at the malignant tumor
• No prior imatinib mesylate
• No prior anticancer therapy that would preclude study participation
• No concurrent therapeutic anticoagulation with warfarin
• No other concurrent investigational drugs
• No concurrent amifostine or other protective reagents

California
      Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
Illinois
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States

Study chairs or principal investigators

Russell J. Schilder, MD,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000069438; GOG-0170E
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041041
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08