Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer; Gastric Cancer
• Interventions: Drug: capecitabine; Drug: oxaliplatin

• Registration Number: NCT00040859
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.

Secondary

* Determine the time to progression and overall survival of patients treated with this regimen.

* Determine the toxic effects of this regimen in these patients.

* Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.

Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Study Timeline

• Study First Submitted: 2002-07-08
• Study Start: 2002-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-01
• Study Completion: 2008-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oxaliplatin + capecitabine	capecitabine	Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
oxaliplatin + capecitabine	oxaliplatin	Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Primary Outcome Measures

Name	Time	Method
Objective tumor response rate	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Time to progression	Up to 3 years
Overall survival	Up to 3 years
Quality of life	Up to 3 years

Trial Locations

Locations (6)

Siouxland Hematology-Oncology Associates, LLP; 🇺🇸 Sioux City, Iowa, United States

Mercy Medical Center - Sioux City; 🇺🇸 Sioux City, Iowa, United States

St. Luke's Regional Medical Center; 🇺🇸 Sioux City, Iowa, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Medical X-Ray Center, PC; 🇺🇸 Sioux Falls, South Dakota, United States

Sanford Cancer Center at Sanford USD Medical Center; 🇺🇸 Sioux Falls, South Dakota, United States