Clinical trial · Interventional
S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer
A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Budget Constraints
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. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Surgery + Chemotherapy
- description
- Preoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
- interventionNames
- Biological: bevacizumab
- Drug: capecitabine
- Drug: oxaliplatin
- Procedure: conventional surgery
Primary outcomes (7)
- measure
- Proportion of patients with R0 resection after treatment
- timeFrame
- 16-18 weeks from registration
- measure
- Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic biopsy * Resectable hepatic metastases by any of the following: * Minor resection (i.e., less than a hemihepatectomy) * Major resection (i.e., hemihepatectomy or extended hepatectomy) * Bilobar resection (including atypical resection) * Synchronous primary tumor and hepatic metastases allowed * Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT scan * Resectable primary colorectal cancer that is in place allowed * Measurable disease * No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 9.0 g/dL * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2.5 times ULN Renal * Creatinine clearance ≥ 60 mL/min * Urine protein/creatinine ratio \< 1 OR * Urine protein \< 1 g by 24-hour urine collection Cardiovascular * No uncontrolled hypertension (i.e., blood pressure \> 150/90 mm Hg) * History of hypertension allowed provided it is well controlled on a stable regimen of anti-hypertensive therapy * No arterial thromboembolic event within the past 12 months, including any of the following: * Transient ischemic attack * Cerebrovascular accident * Unstable angina * Myocardial infarction * No peripheral vascular disease ≥ grade 2 Other * Not pregnant or nursing * Fertile patients must use effective contraception * No pre-existing peripheral neuropathy ≥ grade 2 * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior adjuvant chemotherapy for the primary tumor * No prior systemic chemotherapy for metastatic disease * No prior hepatic artery infusion chemotherapy for metastatic disease Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for metastatic disease Surgery * More than 7 days since prior colonoscopy or fine needle aspiration * More than 28 days since prior major invasive surgery or open biopsy Other * At least 4 weeks since prior and no concurrent sorivudine or brivudine * No prior radiofrequency ablation for metastatic disease * No prior cryotherapy for metastatic disease * No other prior ablative techniques for metastatic disease * No concurrent cimetidine * Concurrent ranitidine or other drug from a different antiulcer class allowed * No concurrent oral anticoagulation for treatment of thrombosis * Concurrent warfarin (1 mg) to maintain patency of central venous catheter allowed
References
Publications (1)
- BACKGROUNDAbdalla EK, Eng C, Madary A, Vauthey JN; Southwest Oncology Group 0408. Southwest Oncology Group 0408: Phase II trial of neoadjuvant capecitabine/oxaliplatin/bevacizumab for resectable colorectal metastases in the liver. Clin Colorectal Cancer. 2006 Mar;5(6):436-9. doi: 10.3816/ccc.2006.n.015. No abstract available. PMID 16635283