Conditions: Colon Cancer Colorectal Cancer Rectal Cancer Cancer Metastatic Cancer Metastatic Colorectal Cancer Oncology
Keywords: k-ras biomarker colorectal colon rectal FOLFOX FOLFIRI
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 116
Healthy volunteers: no

Brief summary:
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.

Detailed description:

Arms:
arm 1: Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.

Interventions: intervention 1: Panitumumab intervention 2: FOLFIRI
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

Protocol document: