Clinical trial NCT01008475
Conditions: Metastatic Colorectal Cancer
Keywords: EMD 525797 Cetuximab Irinotecan metastatic colorectal cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-10-01; Completion date: 2015-04-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.

Detailed description:

Arms: arm 1: EMD 525797 250 mg in combination with cetuximab and irinotecan arm 2: EMD 525797 500 mg in combination with cetuximab and irinotecan arm 3: EMD 525797 750 mg in combination with cetuximab and irinotecan arm 4: EMD 525797 1000 mg in combination with cetuximab and irinotecan arm 5: EMD 525797 500 mg in combination with cetuximab and irinotecan arm 6: EMD 525797 1000 mg (or dose as defined by safety monitoring committee (SMC)\] in combination with cetuximab and irinotecan. arm 7: Cetuximab and irinotecan
Interventions: intervention 1: EMD 525797 250 mg intervention 2: EMD 525797 500 mg intervention 3: EMD 525797 750 mg intervention 4: EMD 525797 1000 mg intervention 5: Cetuximab intervention 6: Irinotecan
Intervention descriptions: intervention 1: EMD 525797 will be administered at a target dose of 250 mg as a 1-hour intravenous infusion for every 2 week until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . intervention 2: Safety part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .

Randomized part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent. intervention 3: EMD 525797 will be administered at a target dose of 750 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent . intervention 4: Safety part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .

Randomized part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent. intervention 5: Safety part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly until DLT.

Randomized part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent. intervention 6: Safety part: Irinotecan will be administered at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .

Randomized part: Irinotecan will be administered at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.

Protocol documents: