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
RATIONALE: 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.
PURPOSE: 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.
Chemotherapeutic Agent Toxicity
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Procedure: assessment of therapy complications
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Designated as safety issue: Yes ]
- Grade of toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Adverse events related to the catheter or the surgical placement of the catheter [ Designated as safety issue: Yes ]
- Objective tumor response (partial or complete) as assessed by RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814086
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Don S. Dizon, MD||Women and Infants Hospital of Rhode Island|
|Study Chair:||Natalie Gould, MD||Rocky Mountain Cancer Centers - Denver Midtown|