Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer

A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.

To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Gemcitabine

Detailed Description

Previous lines of treatment recorded. Adjuvant and palliative.

Treatment will continue until clinical indication due to PD or toxicity, or until completion of 6 cycles of gemcitabine, whichever comes first.

All patients will be assessed for toxicity and followed up for disease recurrence/progression.

The study will be divided into two accrual stages - the first consisting of 17 patients. If 6 or more patients achieve tumour response or stabilisation in the first stage, the second stage will commence accrual of a further 20 patients. Hence, the total planned accrual will be 37 patients.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years
• Histologically proven colorectal adenocarcinoma.
• Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
• Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy
• No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
• Unidimensional measurable disease as assessed by CT.
• Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
• Adequate liver function: Serum Bilirubin <1.5 x upper limit of normal
• Adequate renal function: Serum Creatinine < 0.11 mmol/L
• No concurrent uncontrolled medical conditions
• WHO performance status 0,1 or 2
• Adequate contraceptive precautions, if appropriate
• Informed written consent
• Negative pregnancy test in women of child bearing age
• Life expectancy > 3 months

Exclusion Criteria:

• Medical or psychiatric condition that comprise the patient's ability to take informed consent.
• Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C).
• Previous treatment with gemcitabine.
• Patients with uncontrolled cerebral metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients obtaining disease control in the form of tumour response or stabilisation

Secondary Outcome Measures

Outcome Measure
Progression free survival
Treatment related toxicity

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2004

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): December 16, 2009
• Last Update Submitted That Met QC Criteria: December 15, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: 2398