Colorectal Cancer Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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