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: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 1, 2011
Last Updated Date	May 7, 2012
Start Date ^ICMJE	October 2011
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 11, 2011)	Rate of patients progression free at 3 months [ Time Frame: 3 months after start of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01472770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 11, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Official Title ^ICMJE	A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Metastatic Colorectal Cancer
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	33
Estimated Completion Date	May 2014
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01472770
Other Study ID Numbers ^ICMJE	GemCap
Has Data Monitoring Committee	Yes
Responsible Party	Vejle Hospital
Study Sponsor ^ICMJE	Vejle Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vejle Hospital
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top