Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

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

Summary

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 chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy

• Locally advanced disease defined as any of the following:

• Fixed or immovable tumor on physical exam

• T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI

• T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI

• No distant metastatic disease

• Performance status - ECOG 0-2

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT/SGPT no greater than 2.5 times ULN

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix

• Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse

• No prior or concurrent evidence of neuropathy

• No history of allergy to platinum compounds or antiemetics

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior fluorouracil or platinum-based therapy for any malignancy

• No other concurrent chemotherapy

• Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)

• No prior pelvic irradiation

• No concurrent antiretroviral therapy (HAART) for HIV positive patients