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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01472770

Acronym

GemCaP

Enrollment

Registered

2011-11-16

Start date

2011-10-31

Completion date

2014-05-31

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer, Metastatic, Treatment resistant

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.

Interventions

DRUGGemcitabine + 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of patients progression free at 3 months	3 months after start of treatment

Secondary

Measure	Time frame
Progression free survival	Every 12 weeks
Overall survival	Every 12 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026