This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
PRIMARY OBJECTIVES: I. Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous (IV) paclitaxel followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. SECONDARY OBJECTIVES: I. Assess the toxicity of this regimen in these patients. II. Determine the types of surgical and catheter complications that may occur after surgery or during the course of treatment in these patients. III. Estimate the response rate in patients with measurable disease treated with this regimen. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Given IV or intraperitoneally
Given intraperitoneally
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Women and Infants Hospital
Providence, Rhode Island, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
Time frame: 12 weeks
Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time frame: Up to 1 year
Adverse events related to the catheter or the surgical placement of the catheter
Time frame: Up to 1 year
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time frame: Up to 1 year
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