NCT00733616

Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status

Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	DOX: Docetaxel, oxaliplatin, Capecitabine	* Docetaxel 40 mg/m2, iv infusion 60 minutes, day 1 * Oxaliplatin 80 mg/m2, iv infusion 120 minutes, day 1 * Capecitabine 625 mg/m2, bid, oral, continuous 6 cycles, every 3 weeks Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment)

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-08-13
• Last updated: 2013-02-20

Locations

1 site across 1 country: Spain