At a glance
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A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating cetuximab, capecitabine, and 3 other interventions for Colorectal Cancer. Completed, enrolled 83 participants across 130 sites.
Detailed 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and 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 the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.
Study Details
Timeline
Interventions
Chemotherapy cycle 1: Cetuximab, 400 mg/m\^2, IV, Day 1; Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29 Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
Chemotherapy Cycle 1: Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35) Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29 Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
Surgical resection
IMRT (intensity-modulated radiation therapy)