This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with recurrent or refractory ovarian cancer or primary peritoneal cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells.
PRIMARY OBJECTIVES I. Objective tumour response rate (complete plus partial response as defined by the RECIST criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer. SECONDARY OBJECTIVES: I. Median survival time. II. 6-month survival rate. III. Objective tumour stable disease rate. IV. Response duration. V. Toxicity. VI. Time to disease progression. OUTLINE: This is a multicenter study. Course 1 (56 days): Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Course 2 and all subsequent courses (28 days): Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response receive at least 2 additional courses beyond documented response. Patients with stable or responding disease who have received at least 6 courses may discontinue gemcitabine and continue sorafenib alone until disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Given IV
Given orally
Correlative studies
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada
Objective tumor response rate (complete plus partial response as defined by the RECIST criteria)
Time frame: Up to 7 years
Median survival time
Estimated using the Kaplan Meier method.
Time frame: Up to 7 years
Survival rate
Estimated using the Kaplan Meier method.
Time frame: 6 months
Objective tumor stable disease rate, graded according to RECIST criteria
Ninety-five percent confidence intervals will be provided.
Time frame: Up to 7 years
Response duration
Ninety-five percent confidence intervals will be provided.
Time frame: Up to 7 years
Toxicity, graded using the CTCAE
Time frame: Up to 7 years
Time to disease
Time frame: Up to 7 years
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