Phase I Open Label Trial of Alimta® Plus Cisplatin and Paclitaxel Given Intraperitoneally (IP) as First Line Treatment for Women With Stage III Ovarian Cancer
- To determine the maximum-tolerated dose (MTD) of combination therapy comprising
intraperitoneal (IP) pemetrexed disodium in combination with IP cisplatin and
paclitaxel in patients with optimally debulked stage III ovarian epithelial cancer,
primary peritoneal cancer, or fallopian tube cancer in relation to the percentage of
patients completing at least 6 courses of treatment.
- To determine the toxicity and the tolerability of this regimen in these patients.
- To observe 80% of these patients progression free at 18 months after initiation of
- To determine, as an exploratory endpoint, the median overall survival of patients
treated with this regimen.
- To investigate the pharmacokinetics of this regimen at the determined MTD in these
- To conduct correlative studies on tumor tissue and blood from these patients.
OUTLINE: This is a dose-escalation study of pemetrexed disodium.
Patients receive pemetrexed disodium intraperitoneally (IP) on day 1, cisplatin IP on day 2,
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. At least 10 patients are treated at
the maximum-tolerated dose (MTD).
Whole blood samples and tumor tissue specimens are obtained from patients at baseline and
banked for future DNA, RNA, and protein studies related to prediction of disease progression
and treatment resistance. Plasma and intraperitoneal fluid samples may also be collected
from patients treated at the MTD for pharmacokinetic analysis of plasma concentrations of
pemetrexed disodium by high-performance liquid chromatography (HPLC) or mass
After completion of study therapy, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Setsuko K. Chambers, MD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|Arizona Oncology - Scottsdale||Scottsdale, Arizona 85258|