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:
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
  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:


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

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
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 19, 2014