Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

October 31, 2012

Conditions
Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer
Interventions
DRUG

cisplatin

IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles

DRUG

paclitaxel

IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles

DRUG

pemetrexed disodium

Escalate doses in groups of 3 patients to 60mg per m2, 120 mg per m2, 500 mg per m2, 750 mg per m2, 1000 mg per m2

OTHER

biologic sample preservation procedure

Plasma samples will be collected on the 1st course at baseline, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours (if possible) and 24 hours after the first IP Alimta® dose.

Trial Locations (2)

85258

Arizona Oncology - Scottsdale, Scottsdale

85724-5024

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Arizona

OTHER

NCT00702299 - Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer | Biotech Hunter | Biotech Hunter