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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|