Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists

Unresectable disease
Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
Measurable disease
No known 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 3 times ULN
Alkaline phosphatase no greater than 2 times ULN

Renal:

Creatinine no greater than 1.5 times ULN
Creatinine clearance at least 60 mL/min

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

Able to swallow capecitabine
No unresolved gastrointestinal bleeding
No uncontrolled infection
No chronic debilitating disease
No peripheral neuropathy grade 2 or greater
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

No prior chemotherapy for recurrent or metastatic disease
Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
No other concurrent chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Chemotherapy
No prior radiotherapy for recurrent or metastatic disease
No prior radiotherapy to more than 25% of the bone marrow
Prior adjuvant or neoadjuvant radiotherapy allowed
More than 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery:

More than 4 weeks since prior abdominal exploration with surgical resection
More than 3 weeks since prior abdominal exploration without surgical resection

Other:

No concurrent oral cryotherapy during oxaliplatin administration

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT00040859

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 4 Locations for this study

See Locations Near You

Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT00040859

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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