Clinical trial · Interventional
Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
NCT00321100CI-TRIAL-00055930terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment closed 10/15/2008 based on data about KRAS.
Summary
Brief summary (as posted)
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Drug | Cetuximab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
- description
- Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
- interventionNames
- Drug: bevacizumab
- Drug: cetuximab
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Cetuximab, Oxaliplatin, Capecitabine
- description
- Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
- interventionNames
- Drug: cetuximab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * measurable metastatic adenocarcinoma of the colon or rectum * no prior systemic therapy for metastatic disease * adjuvant therapy must have been completed \>/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed \> 6 months prior to study entry * must have tumor tissue available for EGFR and thymidine phosphorylase evaluation * ECOG PS 0-1 * age \>/= 18 * adequate organ function: WBC\>/=3,000, ANC \>/=1,500, platelets\>/= 100,000, total bilirubin \</= 1.5X ULN, AST\&ALT \</= 2.5X ULN, create clearance \>/= 50mL/min * negative pregnancy test w/in 72 hours of treatment for women of child bearing potential * ability to understand and willing to sign written ICF * able to swallow and absorb oral medication Exclusion Criteria: * medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing) * history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years * surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration * urine protein:creatinine ration \>/=1.0 at screening * evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation) * prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin * underlying neuropathy \>/= grade 2 * TIA or CVA w/in 6 months
References
Publications (1)
- RESULTDotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A phase II study of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as frontline therapy for metastatic colorectal cancer. A Fox Chase extramural research study. J Gastrointest Cancer. 2012 Dec;43(4):562-9. doi: 10.1007/s12029-012-9368-3. PMID 22294255