Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with
ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the
second remission.
OBJECTIVES:
Primary
- To determine the 12-month progression-free survival (PFS) rate of women with ovarian
epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated
with oral sorafenib tosylate.
Secondary
- To determine the safety and tolerability of prolonged treatment with oral sorafenib
tosylate in women with a history of recurrent ovarian cancer.
- To correlate serum markers of angiogenesis (i.e., VEGF and bFGF) and tumor markers
pAKT, HIF-1 α , and VEGF with 12-month PFS.
OUTLINE: Patients receive oral sorafenib twice a day on days 1-28. Treatment repeats every
28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection at baseline, every 12 weeks during
study, and after completion of study therapy for pharmacokinetic studies. Samples are
analyzed for soluble markers of angiogenesis (i.e., VEGF and bFGF) via ELISA and HIF-1 α,
VEGF, and pAKT via IHC staining.
After completion of study treatment, patients are followed at 4 weeks.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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