A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
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 them will develop metastatic disease and thus be candidates for
chemotherapy.
In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as
combination or mono therapy. In recent years biological antibodies targeted against EGFR
have been added to this treatment. A newly developed antibody is Panitumumab, which enables
treatment every 3 weeks instead of weekly administration.
The effect of EGFR activation is mediated through intracellular pathways involving the KRAS
protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly
activated, and patients with these mutations do not benefit from antibodies against EGFR.
Approximately 40% of the patients present these mutations.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Time Frame:
Every 9 weeks. Up to 6 months
Safety Issue:
No
Principal Investigator
Anders Jakobsen, Professor
Investigator Role:
Study Chair
Investigator Affiliation:
Vejle Hospital
Authority:
Denmark: National Board of Health
Study ID:
EudraCT 2008-004923-48
NCT ID:
NCT00792363
Start Date:
November 2008
Completion Date:
August 2011
Related Keywords:
- Metastatic Colorectal Cancer
- KRAS
- Colorectal Neoplasms
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