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

Phase 2
Completed
Conditions
Esophageal Cancer
Gastric Cancer
Interventions
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
docetaxel + capecitabinedocetaxelPatients 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 + capecitabinecapecitabinePatients 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
NameTimeMethod
Proportion of successesUp to 3.5 years
Secondary Outcome Measures
NameTimeMethod
Survival timeUp to 3.5 years
Time to treatment failureUp to 3.5 years
Time to disease progressionUp to 3.5 years
Duration of responseUp to 3.5 years
Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnairesUp to 3.5 years

Trial Locations

Locations (28)

Associates in Womens Health, PA - North Review

🇺🇸

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wellington

🇺🇸

Wellington, Kansas, United States

Cancer Center of Kansas, PA - Winfield

🇺🇸

Winfield, Kansas, United States

Fairview Ridges Hospital

🇺🇸

Burnsville, Minnesota, United States

Cancer Center of Kansas, PA - El Dorado

🇺🇸

El Dorado, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

🇺🇸

Wichita, Kansas, United States

Fairview Southdale Hospital

🇺🇸

Edina, Minnesota, United States

United Hospital

🇺🇸

St. Paul, Minnesota, United States

Cancer Center of Kansas, PA - Kingman

🇺🇸

Kingman, Kansas, United States

Cancer Center of Kansas, PA - Wichita

🇺🇸

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Chanute

🇺🇸

Chanute, Kansas, United States

Southwest Medical Center

🇺🇸

Liberal, Kansas, United States

Cancer Center of Kansas, PA - Dodge City

🇺🇸

Dodge City, Kansas, United States

Cancer Center of Kansas, PA - Newton

🇺🇸

Newton, Kansas, United States

Cancer Center of Kansas, PA - Pratt

🇺🇸

Pratt, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower

🇺🇸

Wichita, Kansas, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Minnesota Oncology Hematology, PA - Maplewood

🇺🇸

Maplewood, Minnesota, United States

Cancer Center of Kansas, PA - Parsons

🇺🇸

Parsons, Kansas, United States

Park Nicollet Cancer Center

🇺🇸

St. Louis Park, Minnesota, United States

Ridgeview Medical Center

🇺🇸

Waconia, Minnesota, United States

Cancer Center of Kansas, PA - Salina

🇺🇸

Salina, Kansas, United States

Mercy and Unity Cancer Center at Mercy Hospital

🇺🇸

Coon Rapids, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

🇺🇸

Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

🇺🇸

Robbinsdale, Minnesota, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury

🇺🇸

Woodbury, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital

🇺🇸

Fridley, Minnesota, United States

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