Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction

• Stage I-III

• Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors

• No disease outside esophagus and peri-esophageal soft tissue

• GE junction tumors must be confined to no greater than 2 cm into the gastric cardia

• Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination

• Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy

• Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm

• No recurrent disease

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm3

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal

• AST/ALT no greater than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• 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

• No grade 2 peripheral neuropathy

• No history of allergy to platinum compounds

• No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No colony-stimulating factor therapy during first study course

Chemotherapy:

• No prior chemotherapy for esophageal cancer

• At least 4 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for esophageal cancer

• At least 4 weeks since other prior radiotherapy

Surgery:

• No prior resection or attempted resection of esophageal cancer

Other:

• No other concurrent investigational drugs

• No other concurrent commercial agents or therapies for esophageal cancer

• No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients