Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study.
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Diphenhydramine hydrochloride (HCl) | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
- description
- * Cetuximab 250 mg/m² / week * Capecitabine 800 mg/m² * Radiotherapy (XRT) * Oxaliplatin 100 mg/m², Days 2 and 23
- interventionNames
- Drug: Cetuximab
- Drug: Oxaliplatin
- Drug: Capecitabine
- Radiation: Radiotherapy
- Drug: Diphenhydramine hydrochloride (HCl)
- type
- EXPERIMENTAL
- label
- Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
- description
- * Cetuximab 250 mg/m² / week * Capecitabine 700 mg/m² * Radiotherapy (XRT) * Oxaliplatin 85 mg/m², Days 2 and 23
- interventionNames
- Drug: Cetuximab
- Drug: Oxaliplatin
- Drug: Capecitabine
- Radiation: Radiotherapy
- Drug: Diphenhydramine hydrochloride (HCl)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge. * Age ≥ 18 * Karnofsky performance status (KPS) ≥ 70 * Leukocyte count \> 3,500 x 10e6/µL * Platelet count \> 100,000/µL * Serum glutamic-oxaloacetic transaminase (SGOT) \< 2.5 x institutional upper limits of normal (ULN) * Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x ULN * Alkaline phosphatase \< 2.5 x ULN * Total bilirubin \< 1.5x ULN * Creatinine: * Within normal institutional limits * OR * Creatinine clearance \> 60 mL/min/1.73 m2 (if serum creatinine levels above institutional normal) * Ability to swallow pills without difficulty * Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication * Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment EXCLUSION CRITERIA * Metastatic (M1) or stage IV disease * Prior history of treatment with cetuximab or other therapy targeting EGFR * Prior history of anti-cancer murine monoclonal antibody therapy * Prior pelvic or whole abdominal radiotherapy * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness / social situations that would limit compliance with study requirements * Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion) * Inability to sign written consent * Pregnant or breastfeeding * Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study
References
Publications (0)
Data not yet available