A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Royal Marsden NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency