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Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations (PG)
This study has been terminated.
(Lacking effect of treatment)
Sponsor:
Vejle Hospital
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01109615
First received: April 20, 2010
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Metastatic Colorectal Cancer | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Factorial Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Vejle Hospital:
Primary Outcome Measures:
- 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 Measures:
- Progression free survival [ Time Frame: Every 3 months until progression or death. Up to 12 months. ]
- Overall survival [ Time Frame: 12 months. ]
| Enrollment: | 40 |
| Study Start Date: | April 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01109615
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109615
Locations
| Denmark | |
| Vejle Hospital | |
| Vejle, Denmark, DK-7100 | |
Sponsors and Collaborators
Vejle Hospital
Investigators
| Study Chair: | Anders Jakobsen, DMSc | Vejle Hospital |
More Information
| Responsible Party: | Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT01109615 History of Changes |
| Other Study ID Numbers: |
2010-018700-90 |
| Study First Received: | April 20, 2010 |
| Last Updated: | April 17, 2012 |
Keywords provided by Vejle Hospital:
|
Colorectal cancer Metastatic colorectal cancer Treatment resistant Chemotherapy refractory KRAS mutation |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 23, 2017