NCT00478946 - A Study of Picoplatin in Colorectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

June 30, 2010

Conditions

Colorectal Cancer

Interventions

DRUG

(FOLPI) Picoplatin with 5-FU and Leucovorin

Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.

DRUG

FOLPI

Picoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.

DRUG

FOLFOX

Oxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.

Trial Locations (16)

115478

Blokhin Russian Oncology Research Center - Phase 1, Moscow

129128

Semashko Central Clinical Hospital #2 - Phase 1, Moscow

150054

Yaroslavl Regional Oncology Center - Phase 1, Yaroslavl

185007

Republic Oncology Center of the Ministry of Healthcare of Karelia Republic - Phase 2, Petrozavodsk

188663

Leningrad Regional Oncology Center, Chemotherapy Department - Phase 2, Kuzmolovsky Village

194291

St. Petersburg Academy of Postgraduate Education - Phase 2, Saint Petersburg

195067

St. Petersburg Mechnikov State Medical Academy - Phase 2, Saint Petersburg

198255

St. Petersburg City Oncology Center - Phase 1, Saint Petersburg

249036

Medical Radiology Research Center of Russian Academy of Medical Sciences- Phase 1, Obninsk

350086

Rostov Research Institute of Oncology- Phase 2, Rostov-na-Dony

394000

Voronezh Regional Clinical Oncology Center - Phase 2, Voronezh

413115

Regional Oncology Center, Chemotherapy Department - Phase 2, Engel's

414041

Regional Oncology Center - Phase 2, Astrakhan

420111

Kazan Oncology Center, Kazan'

432063

Regional Clinical Oncology Center - Phase 2, Ulyanovsk

454087

Chelyabinsk Regional Oncology Center - Phase 1, Chelyabinsk