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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of patients progression free at 3 months

Outcome Time Frame:

3 months after start of treatment

Safety Issue:

No

Authority:

Denmark: Danish Medicines Agency

Study ID:

GemCap

NCT ID:

NCT01472770

Start Date:

October 2011

Completion Date:

May 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal cancer
  • Metastatic
  • Treatment resistant
  • Colorectal Neoplasms

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