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

NCT00220155 | Completed Phase 2

• 1 other identifier: 2398
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Treatment related toxicity

• Progression free survival

Interventions

Gemcitabine DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Gemcitabine

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• David Cunningham

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2004
• Last Updated: December 16, 2009

Record last verified: 2009-12

Locations

GB (1)