Back to resultsA Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer (GemCaP)
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Gemcitabine + Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, Metastatic, Treatment resistant
Eligibility 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.
Sites / Locations
- Department of Oncology, Vejle Hospital
Outcomes
Primary Outcome Measures
Rate of patients progression free at 3 months
Secondary Outcome Measures
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01472770
Brief Title
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Acronym
GemCaP
Official Title
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Colorectal cancer, Metastatic, Treatment resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Capecitabine
Intervention Description
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 Measure Information:
Title
Rate of patients progression free at 3 months
Time Frame
3 months after start of treatment
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
Every 12 weeks
Title
Overall survival
Time Frame
Every 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
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