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
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: Gemcitabine + Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Rate of patients progression free at 3 months [ Time Frame: 3 months after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 33
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472770

Locations
Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01472770     History of Changes
Other Study ID Numbers: GemCap
Study First Received: November 1, 2011
Last Updated: June 14, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:
Colorectal cancer
Metastatic
Treatment resistant

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

ClinicalTrials.gov processed this record on October 19, 2014