Status:
COMPLETED
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
Lead Sponsor:
Vejle Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 colorecta...
Detailed Description
Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00792363
Start Date
November 1 2008
End Date
August 1 2011
Last Update
June 13 2012
Active Locations (1)
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1
Vejle Hospital, Dept. of Oncology
Vejle, Denmark, DK-7100