Clinical trial · Interventional
Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine and oxaliplatin | Drug | — | UNRESOLVED |
| capecitabine and oxaliplatin + cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
- interventionNames
- Drug: capecitabine and oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
- interventionNames
- Drug: capecitabine and oxaliplatin + cetuximab
Primary outcomes (1)
- measure
- Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic colorectal cancer * Unresectable disease * Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by CT scan * Measurable lesion must not be in a previously irradiated area * No prior or current CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal Renal * Creatinine clearance \> 50 ml/min Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past 12 months * No other significant cardiac disease Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 12 months after study participation * Negative pregnancy test * No peripheral neuropathy of any origin \> grade 1 (e.g., alcohol or diabetes) * No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication * No severe reaction attributed to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil or any other component of the trial drugs * No known dihydropyrimidine dehydrogenase deficiency * No other medical condition (e.g., uncontrolled diabetes or active autoimmune disease), geographical situation, or psychiatric disorder that would preclude study compliance * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced or metastatic cancer * At least 6 months since prior adjuvant chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 30 days since prior experimental drugs * No other concurrent experimental drugs * No concurrent drugs that are contraindicated for use with the trial drugs * No other concurrent anticancer therapy * No concurrent sorivudine or any of its chemically-related analogues (e.g., lamivudine)
References
Publications (1)
- RESULTBorner M, Koeberle D, Von Moos R, Saletti P, Rauch D, Hess V, Trojan A, Helbling D, Pestalozzi B, Caspar C, Ruhstaller T, Roth A, Kappeler A, Dietrich D, Lanz D, Mingrone W; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol. 2008 Jul;19(7):1288-1292. doi: 10.1093/annonc/mdn058. Epub 2008 Mar 17. PMID 18349029