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.

Condition	Treatment or Intervention	Phase
Esophageal Cancer Gastric Cancer	Drug: capecitabine  Drug: oxaliplatin  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

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

PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study within 26 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Altru Cancer Center, Grand Forks,  North Dakota,  58201,  United States
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States
Ohio
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000069413; NCCTG-N0149
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00040859
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08