Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations (PG)
Primary Purpose
Metastatic Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Pemetrexed
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, Metastatic colorectal cancer, Treatment resistant, Chemotherapy refractory, KRAS mutation
Eligibility Criteria
Inclusion Criteria:
- Histologically verified adenocarcinoma in colon or rectum
- Age >18
- Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
- KRAS mutation in primary tumour or metastasis.
- Measurable disease according to RECIST
- ECOG performance status 0, 1 or 2
- Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
- EDTA clearance: Uncorrected GFR > 45 ml/min.
- Neutrophilocytes ≥1.5 x 10^9/l, leukocytes ≥3.0 x 10^9/l, thrombocytes ≥100x10^9/l
- ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
- Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
- Fertile men and women (women <2 year after last menstruation) must use efficient birth control.
- Signed informed consent.
Exclusion Criteria:
- Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
- Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
- Other experimental treatment within 30 days prior to treatment start.
- Pregnant or breastfeeding women.
- Clinical or radiological signs of CNS metastases.
- Planned radiation of target lesions.
- Concurrent vaccination against yellow fever.
Sites / Locations
- Vejle Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109615
Brief Title
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Acronym
PG
Official Title
Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Lacking effect of treatment
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (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
This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Colorectal cancer, Metastatic colorectal cancer, Treatment resistant, Chemotherapy refractory, KRAS mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
400 mg/m2 on day 1 of a 3 weeks cycle
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
Every 3 months until progression or death. Up to 12 months.
Title
Overall survival
Time Frame
12 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
Age >18
Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
KRAS mutation in primary tumour or metastasis.
Measurable disease according to RECIST
ECOG performance status 0, 1 or 2
Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
EDTA clearance: Uncorrected GFR > 45 ml/min.
Neutrophilocytes ≥1.5 x 10^9/l, leukocytes ≥3.0 x 10^9/l, thrombocytes ≥100x10^9/l
ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
Fertile men and women (women <2 year after last menstruation) must use efficient birth control.
Signed informed consent.
Exclusion Criteria:
Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
Other experimental treatment within 30 days prior to treatment start.
Pregnant or breastfeeding women.
Clinical or radiological signs of CNS metastases.
Planned radiation of target lesions.
Concurrent vaccination against yellow fever.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jakobsen, DMSc
Organizational Affiliation
Vejle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
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