Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Antibodies, Monoclonal; Camptothecin; Irinotecan; Panitumumab

Criteria

Inclusion Criteria:

• Histologically verified adenocarcinoma in colon or rectum with metastatic spread.

• No mutations in the KRAS gene.

• Resistance to 5-FU, oxaliplatin and irinotecan.

• Age ≥18 years.

• PS 0-2.

• Measurable disease according to RECIST criteria.

• Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.

• Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.

• Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.

• Oral and written informed consent.

Exclusion Criteria:

• Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.

• Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.

• Verified or clinically suspected CNS metastasis.

• Other experimental treatment.

• Serious medical disease according to investigator's judgement.

• Pregnant or breastfeeding women.

• Hypersensitivity to the active substance or to one or more of the auxiliary substances.

• Patients with interstitial pneumonitis or pulmonary fibrosis.