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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472770
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Vejle Hospital

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Gemcitabine + Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Study Start Date : October 2011
Primary Completion Date : May 2013
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. Rate of patients progression free at 3 months [ Time Frame: 3 months after start of treatment ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every 12 weeks ]
  2. Overall survival [ Time Frame: Every 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472770

Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT01472770     History of Changes
Other Study ID Numbers: GemCap
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Vejle Hospital:
Colorectal cancer
Treatment resistant

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs