NCT00814086

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given IV or intraperitoneally
DRUG	Cisplatin	Given intraperitoneally

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• First posted: 2008-12-23
• Last updated: 2014-12-31

Locations

7 sites across 1 country: United States