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

Metastatic Colorectal Cancer Clinical Trial

— GemCaP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472770
• Other study ID #: GemCap
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: December 3, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients progression free at 3 months		3 months after start of treatment	No
Secondary	Progression free survival		Every 12 weeks	No
Secondary	Overall survival		Every 12 weeks	No