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COUGAR-02: Docetaxel in Relapsed Esophago-gastric Cancer
NCT00978549Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2008
- Primary completion
- Apr 2010
- Countries
- 1
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- esophageal adenocarcinoma (EAC)gastric adenocarcinomagastroesophageal junction adenocarcinoma
01
Overview
Phase 3, randomised, open-label trial of docetaxel in esophageal adenocarcinoma (EAC), gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (2 arms), sponsored by Cambridge University Hospitals NHS Foundation Trust. Primary endpoint: Overall Survival. Started Apr 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Docetaxel + ASC
Docetaxel IV over 1 hour on day 1 every 3 weeks + Active Symptom Control
Active Symptom Control
Active Symptom Control (analgesics, antiemetics, steroids, radiotherapy)
03
Who it enrols
Patients with histologically confirmed adenocarcinoma of the esophagus, stomach, or esophagogastric junction who have progressed on or within 6 months of first-line platinum/fluoropyrimidine chemotherapy. Patients must have ECOG PS 0-2 and no prior taxane therapy.
04
Endpoints
Primary
Overall Survival
Secondary
Time to Documented Progression
Response Rate
Toxicity
Quality of Life
Health Economic Evaluation
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