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Clinical Trials/NCT01472770
NCT01472770
Completed
Phase 2

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

Vejle Hospital1 site in 1 country49 target enrollmentOctober 2011
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ConditionsMetastatic Colorectal Cancer
DrugsGemcitabine + Capecitabine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Metastatic Colorectal Cancer
Sponsor
Vejle Hospital
Enrollment
49
Locations
1
Primary Endpoint
Rate of patients progression free at 3 months
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of patients progression free at 3 months

Time Frame: 3 months after start of treatment

Secondary Outcomes

  • Overall survival(Every 12 weeks)
  • Progression free survival(Every 12 weeks)

Study Sites (1)

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