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

NCT01472770 | Completed Phase 2 DMC

• 1 other identifier: GemCap
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; Metastatic; Treatment resistant

Outcome Measures

Primary Outcomes (1)

• Rate of patients progression free at 3 months

  3 months after start of treatment

Secondary Outcomes (2)

• Progression free survival

  Every 12 weeks

• Overall survival

  Every 12 weeks

Interventions

Gemcitabine + Capecitabine DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinically significant concurrent disease.
• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

DK (1)