Trials / Completed
CompletedNCT00220155
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Royal Marsden NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine |
Timeline
- Start date
- 2004-05-01
- First posted
- 2005-09-22
- Last updated
- 2009-12-16
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00220155. Inclusion in this directory is not an endorsement.