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Completed

NCT Number: NCT01472770

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine + Capecitabine

Drug

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 outcomes

  1. Rate of patients progression free at 3 months

    Time frame: 3 months after start of treatment

Secondary outcomes

  1. Progression free survival

    Time frame: Every 12 weeks

  2. Overall survival

    Time frame: Every 12 weeks

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Acronym: GemCaP

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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