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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Conditions
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Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma, Gastrointestinal Complication, Malignant Ovarian Mixed Epithelial Tumor, Neurotoxicity Syndrome, Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Carcinoma, Stage II Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Undifferentiated Ovarian Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (paclitaxel, cisplatin)<br>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. | Drug: Paclitaxel<br>* Given IV or intraperitoneally<br>* Other names: TAX;Drug: Cisplatin<br>* Given intraperitoneally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) |  | Up to 1 year | 
| Adverse events related to the catheter or the surgical placement of the catheter |  | Up to 1 year | 
| Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) |  | Up to 1 year |