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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01472770
First received: November 1, 2011
Last updated: June 14, 2013
Last verified: June 2013

November 1, 2011
June 14, 2013
October 2011
May 2013   (final data collection date for primary outcome measure)
Rate of patients progression free at 3 months [ Time Frame: 3 months after start of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472770 on ClinicalTrials.gov Archive Site
  • Progression free survival [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
Drug: Gemcitabine + Capecitabine
Gemcitabine: 1000 mg/m2 intravenously over 30 min. on day 1 in 2-weeks cycles. Capecitabine: Peroral tablet 2000 mg/m2 daily on days 1-7 in 2-weeks cycles.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
May 2014
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01472770
GemCap
Yes
Vejle Hospital
Vejle Hospital
Not Provided
Not Provided
Vejle Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP