A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer (GemCaP)

December 3, 2014 updated by: Vejle Hospital
The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

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, 7100
        • Department of Oncology, 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 colorectal adenocarcinomas
  • Age > 18 years
  • Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
  • Measurable disease according to RECIST 1.1
  • ECOG performance status 0, 1 or 2
  • Adequate renal, hepatic and haematological function
  • Consent to blood samples and available paraffin embedded tumour material for translational research studies
  • Fertile males and females (<2 years after last period for women) must use effective birth control.
  • Signed Informed consent

Exclusion Criteria:

  • Clinically significant concurrent disease.
  • Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
  • Other experimental therapy within 30 days of treatment initiation.
  • Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
  • Clinical or radiological evidence of CNS metastasis.
  • Planned radiation therapy against target-lesions.
  • Known allergy to 5FU/capecitabine or gemcitabine.

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients progression free at 3 months
Time Frame: 3 months after start of treatment
3 months after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: Every 12 weeks
Every 12 weeks
Overall survival
Time Frame: Every 12 weeks
Every 12 weeks

Collaborators and Investigators

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

Sponsor

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

October 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 11, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GemCap

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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