RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).

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

Further Study Details: 

OBJECTIVES:

• Determine total response rate in patients with metastatic or inoperable locally advanced gastric or gastroesophageal junction adenocarcinoma treated with oxaliplatin, irinotecan, and capecitabine.
• Determine the duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
• Metastatic or inoperable locally advanced disease
• Measurable disease
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.5 g/dL

Hepatic

• AST and ALT ≤ 2 times upper limit of normal
• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine ≤ 1.5 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No New York Heart Association class III or IV heart disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• Able to take oral medications
• No prior allergic reaction to compounds of similar chemical or biological composition to oxaliplatin, irinotecan, or capecitabine
• No known hypersensitivity to fluorouracil
• No concurrent uncontrolled illness
• No neuropathy grade 3 or greater
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent sargramostim (GM-CSF)

Chemotherapy

• More than 4 weeks since prior chemotherapy and recovered
• No more than 1 course of prior neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiotherapy as primary treatment
• No prior chemotherapy for metastatic or recurrent disease

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• At least 4 weeks since prior anticancer therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or commercial agents
• No other concurrent anticancer therapy

Michigan
      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-1714,  United States; Recruiting
Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study chairs or principal investigators

Joanna M. Brell, MD,  Principal Investigator,  Ireland Cancer Center   

Study ID Numbers:  CDR0000365464; CWRU-010442; CWRU-CASE-1203; NCI-6449; NCT00084617
Record last reviewed:  February 2005
Last Updated:  April 5, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084617
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08