NCT00517829

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.

Detailed description

This is a Phase II, open- label, randomized, noncomparative study. Patients will be stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS. Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 - Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle. Treatment will continue until disease progression or intolerable toxicity. Patients who achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to 24 months of participation, counted from the date of the first dose of study drug.

Conditions

• Gastric Cancer Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Docetaxel	Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
DRUG	cetuximab	ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
DRUG	oxaliplatin	Eloxatin 130 mg/m2 IV over 2 hours

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-08-17
• Last updated: 2016-11-28
• Results posted: 2016-02-11

Locations

47 sites across 1 country: United States