Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00220155|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Gemcitabine||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.|
|Study Start Date :||May 2004|
- Proportion of patients obtaining disease control in the form of tumour response or stabilisation
- Treatment related toxicity
- Progression free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220155
|Royal Marsden Hospital|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||David Cunningham||Royal Marsden NHS Foundation Trust|