Primary Peritoneal Cavity Cancer Clinical Trial
Official title:
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
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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