Back to resultsIrinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Irinotecan
Panitumumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring KRAS
Eligibility 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.
Sites / Locations
- Vejle Hospital, Dept. of Oncology
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
Overall survival
Progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00792363
Brief Title
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
Official Title
A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 colorectal cancer without KRAS mutations.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
KRAS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
350 mg/m2 intravenously on day 1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Intervention Description
9 mg/kg intravenously on day 1 every 3 weeks
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
Every 9 weeks. Up to 6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
6 months
Title
Progression free survival
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jakobsen, Professor
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital, Dept. of Oncology
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
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