Bortezomib, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Rectal Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bortezomib and fluorouracil together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fluorouracil and external-beam radiation therapy in treating patients with stage II, stage III, or stage IV rectal cancer.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Biopsy confirmed diagnosis of adenocarcinoma of the rectum meeting 1 of the following clinical staging criteria:

• T3-T4, N0, M0 (stage II disease)

• T4 disease defined as tumor fixed on examination or involving adjacent pelvic structures, such as the sidewall, bladder, uterus, prostate, or small bowel by ultrasound or CT scan

• Any T, N1-2, M0 (stage III disease)

• Any T, any N, M1 (stage IV disease)

• Recurrent disease (any prior stage)

• Candidate for local palliative therapy or curative resection of metastatic disease

• Previously treated CNS disease allowed provided it is stable for > 3 months

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• Adequate nutrition

• WBC ≥ 4,000/mm³

• ANC > 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min

• Bilirubin ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious medical or psychiatric illness that would limit study compliance or limit survival to < 2 years

• No history of refractory congestive heart failure or cardiomyopathy

• No active coronary artery disease, myocardial infarction within the past 3 months, or cerebrovascular accident within the past 3 months

• No peripheral neuropathy ≥ grade 2

• No hypersensitivity to bortezomib, boron, or mannitol

PRIOR CONCURRENT THERAPY:

• More than 1 week since prior major surgery

• More than 28 days since prior investigational agents

• Prior chemotherapy allowed

• No prior pelvic radiotherapy (for treatment of any pelvic malignancy)

• No concurrent herbal medication (excluding vitamin and mineral supplements)

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)