A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day One Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
- Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous paclitaxel
followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian
epithelial, fallopian tube, or primary peritoneal cavity cancer.
- Assess the toxicity of this regimen in these patients.
- Determine the types of surgical and catheter complications that may occur after surgery
or during the course of treatment in these patients.
- Estimate the response rate in patients with measurable disease treated with this
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.
Masking: Open Label, Primary Purpose: Treatment
The number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks during the first 4 courses of treatment
Don S. Dizon, MD
Women and Infants Hospital of Rhode Island
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|