A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- imatinib mesylate
- Conditions
- Primary Peritoneal Cavity Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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
Detailed 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.
Investigators
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)
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (imatinib mesylate)
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.
Intervention: imatinib mesylate
Treatment (imatinib mesylate)
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: At 6 months
Frequency and severity of adverse effects as assessed by CTC
Time Frame: Up to 7 years
Secondary Outcomes
- Duration of overall survival(Up to 7 years)
- Duration of progression-free survival(Up to 7 years)
- Frequency of clinical response (partial and complete response)(Up to 7 years)
- Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology(Baseline)