Ovarian Cancer Clinical Trial
Cisplatin and 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
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Stage IIB, IIC, III, or IV disease
Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
Appropriate tissue for histologic evaluation available
The following histologic epithelial cell types are eligible:
Serous adenocarcinoma
Endometrioid adenocarcinoma
Mucinous adenocarcinoma
Undifferentiated carcinoma
Clear cell adenocarcinoma
Mixed epithelial carcinoma
Transitional cell carcinoma
Malignant Brenner tumor
Adenocarcinoma not otherwise specified
Carcinosarcoma
No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
Stage ≤ IB disease
No more than superficial myometrial invasion, without vascular or lymphatic invasion
No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
GOG performance status 0-2
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
SGOT ≤ 2.5 times ULN
Audiograms required after study chemotherapy courses 3 and 6 for patients with hearing loss, or who are experiencing tinnitus during study therapy
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
None of the following:
Septicemia
Severe infection requiring parenteral antibiotics
Malnutrition requiring parenteral hyperalimentation
Acute hepatitis
Any other major medical conditions expected to interfere with completion of protocol therapy
No active bleeding
No circumstances that would prohibit completion of study therapy or required follow-up
No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
No other invasive malignancies, except for nonmelanoma skin cancer or other specific malignancies within the past 5 years, or whose previous cancer treatment contraindicates this protocol therapy
No unstable angina or myocardial infarction within the past 6 months
Abnormal cardiac conduction (e.g., bundle branch block or heart block) that has been stable for the past 6 months allowed
No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:
Vaccines
Antibodies
Tyrosine kinase inhibitors
No prior chemotherapy
No prior radiotherapy
No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer
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There are 7 Locations for this study
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Camden New Jersey, 08103, United States
Columbus Ohio, 43214, United States
Tulsa Oklahoma, 74146, United States
Providence Rhode Island, 02905, United States
Madison Wisconsin, 53792, United States
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