Conditions: Recurrent Colorectal Carcinoma Progressive Colorectal Carcinoma
Keywords: Colorectal Carcinoma Recurrent Progressive Cetuximab Irinotecan 5-Fluorouracil
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.

Detailed description:

Arms:
arm 1: Treatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 2: Treatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 3: Treatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 4: Treatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. arm 5: Treatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab. arm 6: Treatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.

Interventions: intervention 1: Imprime PGG 2 mg/kg intervention 2: Imprime PGG 4 mg/kg intervention 3: Cetuximab intervention 4: Irinotecan intervention 5: Imprime PGG 6mg/kg
Intervention descriptions: intervention 1: Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops. intervention 3: 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; intervention 4: Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle intervention 5: Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

Protocol document: