Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Capecitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed gastric cancer

• Locally advanced, unresectable, or metastatic disease

• Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• WBC ≥ 3,000/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin normal

• AST/ALT ≤ 2.5 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during study and for 6 months after completion of study treatment

• Able to swallow

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluoropyrimidines or platinum chemotherapy agents

• No uncontrolled intercurrent illness including, but not limited to the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered

• At least 6 months since prior radiotherapy with capecitabine as a radioenhancer

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent chemotherapy

• No concurrent palliative radiotherapy

• No concurrent hormonal therapy except for the following:

• Steroids for adrenal failure

• Hormones for nondisease related conditions (e.g., insulin for diabetes)

• Intermittent use of dexamethasone as an antiemetic

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies