Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)

At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)
No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation

Measurable disease*

The following are not considered measurable disease:

Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Lymphangitis cutis/pulmonis
Abdominal masses that are not confirmed and followed by imaging
Cystic lesions NOTE: *Patients having only lesions measuring ≥ 1 cm to < 2 cm must use spiral CT scan for all tumor assessments.
No untreated or treated but symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 12 weeks

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
AST no greater than 2.5 times ULN if alkaline phosphatase is less than ULN OR
Alkaline phosphatase no greater than 4 times ULN if AST less than ULN

Renal

Creatinine normal
Creatinine clearance at least 60 mL/min

Cardiovascular

No New York Heart Association class III or IV heart disease

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Ability to swallow capecitabine
No prior anaphylactic reaction to any taxane
No prior severe reaction to fluoropyrimidine
No prior poor tolerance to capecitabine
No known sensitivity or poor tolerance to fluorouracil
No known dihydropyrimidine dehydrogenase deficiency
No uncontrolled infection
No uncontrolled seizure disorder
No chronic debilitating disease
No peripheral neuropathy of any etiology greater than grade 1
No diabetes mellitus
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy or biologic therapy for recurrent or metastatic disease
No concurrent biologic therapy

Chemotherapy

No prior chemotherapy for recurrent or metastatic disease except for the following:

Adjuvant chemotherapy after complete resection of the original tumor
Neoadjuvant chemotherapy followed by surgical resection of the original tumor
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy except for the following:

Adjuvant radiotherapy after complete resection of the original tumor
Neoadjuvant radiotherapy followed by surgical resection of the original tumor
No prior radiotherapy to 25% or more of the bone marrow
More than 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery

See Disease Characteristics
No prior organ allograft

Other

No concurrent brivudine or sorivudine

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00054457

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 24 Locations for this study

See Locations Near You

Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
St. Louis Park Minnesota, 55416, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00054457

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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