Ovarian Cancer Clinical Trial
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Full Description
PRIMARY OBJECTIVES:
I. To evaluate the cytostatic, anti-tumor activity of Gleevec (Imatinib Mesylate) through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec.
II. To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC.
SECONDARY OBJECTIVES:
I. To determine the distribution of the overall survival. II. To determine the distribution of progression-free survival. III. To estimate the clinical response rate (partial and complete response as defined under the RECIST criteria).
IV. To assess the effects of prognostic variables: initial performance status, platinum sensitivity, and mucinous (or clear cell) histology).
TERTIARY OBJECTIVES:
I. To determine the levels of expression of c-KIT and its ligand, stem cell factor (SCF) in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
II. To determine the levels of expression of platelet derived growth factor receptor (PDGFR) and its ligand PDGF in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
III. To determine the levels of expression of AKT2 and its activated form, phospho-AKT2, in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
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.
Eligibility Criteria
Inclusion Criteria:
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)
Performance status - GOG 0-2 (if patient has received one prior treatment regimen)
Performance status - GOG 0-1 (if patient has received two prior treatment regimens)
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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
Creatinine no greater than 1.5 times ULN
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
At least 3 weeks since prior immunologic therapy directed at the malignant tumor
No concurrent biologic therapy or immunotherapy for the malignant tumor
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
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
Recovered from prior radiotherapy
No prior radiotherapy to more than 25% of marrow-bearing areas
No concurrent anticancer radiotherapy
Recovered from recent prior surgery
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19103, United States
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