S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:

• Newly diagnosed disease amenable to curative resection

• Stage IB-III (T2-4)

• Measurable or nonmeasurable disease

• Enlarged lymph nodes outside of radiation fields must have preoperative biopsies

• No positive lymph nodes outside of radiation fields

• No distant metastasis

• No gastroesophageal junction tumors

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm³

• WBC ≥ 3,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 times upper limit of normal

• Albumin ≥ 3 g/dL

• Bilirubin normal

• No evidence of ischemic heart disease by EKG

• No coronary artery disease requiring active medical treatment

• No symptoms of angina

• No history of myocardial infarction

• No deep vein thrombosis within the past 12 months

• No pre-existing peripheral neuropathy

• No active pneumonia or inflammatory lung infiltrate

• No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years

• No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no concurrent sorivudine or brivudine

• No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy

• No prior coronary angioplasty or stenting

• No concurrent 2-dimensional or intensity-modulated radiotherapy