Intraperitoneal Paclitaxel, Doxorubicin, and Cisplatin in Treating Patients With Endometrial Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cisplatin, 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 intraperitoneal paclitaxel when given together with doxorubicin and cisplatin in treating patients with endometrial cancer.
Drug: doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure|
- Assessment of acute toxicity during courses 3-4 to identify maximum tolerated dose [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
- To determine the maximum tolerated dose of intraperitoneal (IP) paclitaxel when given concurrently with fixed dose IV doxorubicin hydrochloride and IV cisplatin in patients with endometrial cancer at high-risk for peritoneal failure.
- To determine the maximum tolerated dose of IP paclitaxel when given concurrently with fixed dose IV doxorubicin hydrochloride and IP cisplatin.
- To determine the feasibility of an IV/IP based doxorubicin hydrochloride, paclitaxel, and cisplatin chemotherapy regimen in patients with advanced endometrial cancer.
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive doxorubicin hydrochloride IV over 50 minutes followed by cisplatin IV over 1 hour on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim (G-CSF) IV on days 3-12 or pegfilgrastim subcutaneously on day 3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive doxorubicin hydrochloride IV, cisplatin IV or intraperitoneally (IP), and paclitaxel IP on day 1 or day 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Seiko D. Yamada 773-834-7424|
|Principal Investigator: Seiko D. Yamada|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Koen De Geest 800-237-1225|
|Principal Investigator: Koen De Geest|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: David G. Mutch 800-600-3606 email@example.com|
|Principal Investigator: David G. Mutch|
|United States, New Jersey|
|Cooper Hospital University Medical Center||Active, not recruiting|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Steven E. Waggoner 800-641-2422|
|Principal Investigator: Steven E. Waggoner|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Robert S. Mannel 405-271-4272 firstname.lastname@example.org|
|Principal Investigator: Robert S. Mannel|
|Study Chair:||D. Scott McMeekin, MD||Oklahoma University Cancer Institute|