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

April 17, 2012 updated by: Vejle Hospital

Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 12 months.
12 months.
Progression free survival
Time Frame: Every 3 months until progression or death. Up to 12 months.
Every 3 months until progression or death. Up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Anders Jakobsen, DMSc, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-018700-90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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