Endometrial Serous Adenocarcinoma Clinical Trial
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
This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when given together with doxorubicin hydrochloride and cisplatin in treating patients with stage III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, 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.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of intraperitoneal (IP) paclitaxel when given
concurrently with fixed dose intravenous (IV) doxorubicin (doxorubicin hydrochloride) and IV
cisplatin.
II. To determine the maximum tolerated dose of IP paclitaxel when given concurrently with
fixed dose IV doxorubicin hydrochloride and IP cisplatin.
III. 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 dose-escalation study of paclitaxel.
Patients receive doxorubicin hydrochloride IV over 30 minutes followed by cisplatin IV over 1
hour on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim subcutaneously (SC) on
days 3-12 or pegfilgrastim SC 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 and cisplatin IV or IP on day 1, and
paclitaxel IP on days 1 or 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 up every 3 months for 1 year.
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