Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Recurrent Colorectal CarcinomaProgressive Colorectal Carcinoma
Interventions
BIOLOGICAL

Imprime PGG 2 mg/kg

Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

BIOLOGICAL

Imprime PGG 4 mg/kg

Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.

BIOLOGICAL

Cetuximab

Infusion 400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;

DRUG

Irinotecan

Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle

BIOLOGICAL

Imprime PGG 6mg/kg

Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

Trial Locations (2)

Unknown

Medical City, Makati City

Philippine General Hospital, Manila

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HiberCell, Inc.

INDUSTRY

NCT00545545 - Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma | Biotech Hunter | Biotech Hunter