Conditions: Rectal Cancer Colo-rectal Cancer
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 23
Healthy volunteers: no

Brief 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.

Arms:
arm 1: * Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23 arm 2: * Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23 arm 3: * Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT) arm 4: * Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)

Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Radiotherapy intervention 5: Diphenhydramine hydrochloride (HCl)
Intervention descriptions: intervention 1: 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) intervention 2: Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23. intervention 3: Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses intervention 4: Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy) intervention 5: Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Protocol document: