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: | Endpoint Classification: Safety/Efficacy Study 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:
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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: Every 3 months until progression or death. Up to 12 months. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 12 months. ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided
| 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 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: Ethics Committee |
Keywords provided by Vejle Hospital:
|
Colorectal cancer Metastatic colorectal cancer Treatment resistant Chemotherapy refractory KRAS mutation |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Gemcitabine Pemetrexed Anti-Infective Agents |
Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015