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

This study has been completed.
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: September 20, 2005
Last updated: December 15, 2009
Last verified: December 2009
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.

Condition Intervention Phase
Colorectal Cancer Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.

Resource links provided by NLM:

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Proportion of patients obtaining disease control in the form of tumour response or stabilisation

Secondary Outcome Measures:
  • Treatment related toxicity
  • Progression free survival

Enrollment: 16
Study Start Date: May 2004
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00220155

United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust Identifier: NCT00220155     History of Changes
Other Study ID Numbers: 2398
Study First Received: September 20, 2005
Last Updated: December 15, 2009

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017