Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction

Phase 2

Completed

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

• Registration Number: NCT00054457
• 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 of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.

Detailed Description

OBJECTIVES:

* Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.

* Determine the time to progression in patients treated with this regimen.

* Determine the overall survival in patients treated with this regimen.

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

* Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis.

* Assess the quality of life and swallowing uniscale during chemotherapy in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.

Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.

Study Timeline

• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Study Start: 2003-09
• Primary Completion: 2007-02
• Study Completion: 2008-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel + capecitabine	docetaxel	Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
docetaxel + capecitabine	capecitabine	Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.

Primary Outcome Measures

Name	Time	Method
Proportion of successes	Up to 3.5 years

Secondary Outcome Measures

Name	Time	Method
Time to treatment failure	Up to 3.5 years
Time to disease progression	Up to 3.5 years
Duration of response	Up to 3.5 years
Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires	Up to 3.5 years
Survival time	Up to 3.5 years

Trial Locations

Locations (28)

Cancer Center of Kansas, PA - Chanute; 🇺🇸 Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City; 🇺🇸 Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado; 🇺🇸 El Dorado, Kansas, United States

Cancer Center of Kansas, PA - Kingman; 🇺🇸 Kingman, Kansas, United States

Southwest Medical Center; 🇺🇸 Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton; 🇺🇸 Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons; 🇺🇸 Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt; 🇺🇸 Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina; 🇺🇸 Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington; 🇺🇸 Wellington, Kansas, United States

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