Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: sorafenib tosylate
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival (PFS) rate at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety and tolerability of prolonged treatment as assessed by NCI CTCAE v3.0 in patients with a history of recurrent ovarian cancer [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Correlation of serum markers of angiogenesis (i.e., VEGF and bFGF) as assessed by ELISA and tumor markers (i.e., pAKT, HIF-1 α, and VEGF) as assessed by IHC with the 12-month PFS rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: Oral Sorafenib (BAY43-9006)
Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intolerable toxicity, a patient may continue to receive treatment with sorafenib until disease progression, or until 24 months have elapsed.
|Drug: sorafenib tosylate Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522301
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||William P. Tew, MD||Memorial Sloan Kettering Cancer Center.|
|Principal Investigator:||Paul Sabbatini, MD||Memorial Sloan Kettering Cancer Center.|