Clinical trial · Interventional
Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver
NCT00070265CI-TRIAL-00009077terminatedPhase 2ClinicalTrials.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): Administratively complete.
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed. Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oxaliplatin, capecitabine, and surgery)
- description
- Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor. Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.
- interventionNames
- Drug: oxaliplatin
- Drug: capecitabine
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Rate of complete resection (R0 resection)
- timeFrame
- Up to 5 years
- description
- The design of Thall and Simon will be used.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy * Imaging evidence of liver metastasis by CT helical scan * Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year) * Resectable, defined as a sparing of 2 adjacent liver segments with adequate vascular inflow and outflow and hepatic remnant volume * Minor resections (less than a hemihepatectomy) or major resections (hemihepatectomy or extended hepatectomy) allowed * Bilobar resection allowed, including atypical resections * No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis * Performance status - Zubrod 0-1 * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 2 mg/dL * AST and ALT no greater than 300 IU/L * No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis) that would preclude surgical resection of metastases * Creatinine no greater than 1.5 mg/dL * Creatinine clearance 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix * No preexisting grade 2 or greater peripheral neuropathy * No concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No concurrent biologic therapy * No concurrent sargramostim (GM-CSF) * More than 6 months since prior adjuvant fluorouracil-based chemotherapy * No prior chemotherapy for liver metastasis * No prior oxaliplatin for colorectal cancer * No prior or concurrent hepatic artery infusion chemotherapy for metastatic disease * No prior or concurrent radiotherapy for metastatic disease * No prior or concurrent radiofrequency ablation for metastatic disease * No prior or concurrent cryotherapy/other ablative techniques for metastatic disease * No other concurrent investigational therapy * No concurrent oral anticoagulation
References
Publications (0)
Data not yet available
No reference posted for this study.