A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Phase 2
Completed
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- NCT01472770
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rate of patients progression free at 3 months 3 months after start of treatment
- Secondary Outcome Measures
Name Time Method Overall survival Every 12 weeks Progression free survival Every 12 weeks
Trial Locations
- Locations (1)
Department of Oncology, Vejle Hospital
🇩🇰Vejle, Denmark