NCT00226941

A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer

A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: George Albert Fisher · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to: 1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 2. To determine the maximum-tolerated dose (MTD) when capecitabine * oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)

Detailed description

Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2). In Phase 1, the objectives are to 1. Assess dose-limiting toxicities (DLTs) and 2. Determine a maximum-tolerated dose (MTD) The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery. Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all study participants at the time of, or after, surgery, as measured by the pathologic response rate; downstaging; and survival at 5 years from the start of treatment.

Conditions

• Rectal Cancer
• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)
DRUG	Oxaliplatin	Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.
DRUG	Capecitabine	Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses
RADIATION	Radiotherapy	Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy)
DRUG	Diphenhydramine hydrochloride (HCl)	Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-03-01
• Completion: 2009-02-01
• First posted: 2005-09-27
• Last updated: 2017-12-08
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study