Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.|
- Proportion of patients obtaining disease control in the form of tumour response or stabilisation
- Treatment related toxicity
- Progression free survival
|Study Start Date:||May 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220155
|Royal Marsden Hospital|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||David Cunningham||Royal Marsden NHS Foundation Trust|