Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations (PG)
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ClinicalTrials.gov Identifier: NCT01109615 |
Recruitment Status :
Terminated
(Lacking effect of treatment)
First Posted : April 23, 2010
Last Update Posted : April 19, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Colorectal Cancer | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Chemotherapy |
Drug: Pemetrexed
400 mg/m2 on day 1 of a 3 weeks cycle Drug: Gemcitabine 1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle |
- 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. ]
- Progression free survival [ Time Frame: Every 3 months until progression or death. Up to 12 months. ]
- Overall survival [ Time Frame: 12 months. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109615
Denmark | |
Vejle Hospital | |
Vejle, Denmark, DK-7100 |
Study Chair: | Anders Jakobsen, DMSc | Vejle Hospital |
Responsible Party: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT01109615 |
Other Study ID Numbers: |
2010-018700-90 |
First Posted: | April 23, 2010 Key Record Dates |
Last Update Posted: | April 19, 2012 |
Last Verified: | April 2012 |
Colorectal cancer Metastatic colorectal cancer Treatment resistant Chemotherapy refractory KRAS mutation |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Gemcitabine Pemetrexed |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |