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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Treatment related toxicity
Progression free survival
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.