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Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations (PG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01109615
Recruitment Status : Terminated (Lacking effect of treatment)
First Posted : April 23, 2010
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Pemetrexed Drug: Gemcitabine Phase 2

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Progression free survival [ Time Frame: Every 3 months until progression or death. Up to 12 months. ]
  2. Overall survival [ Time Frame: 12 months. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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Denmark
Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Investigators
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Study Chair: Anders Jakobsen, DMSc Vejle Hospital
More Information
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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
Keywords provided by Vejle Hospital:
Colorectal cancer
Metastatic colorectal cancer
Treatment resistant
Chemotherapy refractory
KRAS mutation
Additional relevant MeSH terms:
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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