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

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220155
First received: September 20, 2005
Last updated: December 15, 2009
Last verified: December 2009
History of Changes

September 20, 2005
December 15, 2009
May 2004
Not Provided
Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Same as current
Complete list of historical versions of study NCT00220155 on ClinicalTrials.gov Archive Site
  • Treatment related toxicity
  • Progression free survival
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: Gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220155
2398
No
Jane Lawrence, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP