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
- 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.
Primary Purpose: Treatment
Assessment of acute toxicity during courses 3-4 to identify maximum tolerated dose
D. Scott McMeekin, MD
Oklahoma University Cancer Institute
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|