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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Oncology, Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GemCap

Identifier Type: -

Identifier Source: org_study_id