Clinical trial · Interventional
Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)
- 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 oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known which regimen works better in treating advanced colorectal cancer. PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic or recurrent disease not amenable to potentially curative treatment * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Histological or cytological confirmation is required for a solitary target lesion * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGPT and SGOT no greater than 3 times ULN Renal * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 30 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No clinical evidence of congestive heart failure * No unstable coronary artery disease Pulmonary * No interstitial pneumonia * No extensive symptomatic fibrosis of the lungs Gastrointestinal * Able to tolerate oral medication * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No swallowing difficulties Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No other concurrent serious illness * No uncontrolled infection * No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or any other cancer for which the patient has been off all therapy and in remission for at least 5 years * No peripheral neuropathy * No hypersensitivity to any of the study drugs or their ingredients * No known dihydropyrimidine dehydrogenase deficiency * No other medical or psychiatric disorder that would preclude giving informed consent or complying with study PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic hematopoietic growth factor therapy * No prior bevacizumab (Avastin™) Chemotherapy * At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and irinotecan * No prior oxaliplatin * No prior chemotherapy for metastatic or recurrent disease * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy unless for the control of bone pain Surgery * Recovered from prior surgery * No prior organ allografts Other * More than 4 weeks since prior investigational drugs * No concurrent iced mouth rinses for the prevention of stomatitis * No concurrent cold cap alopecia prevention * No concurrent pyridoxine * No concurrent sorivudine or chemically-related analogues (e.g., brivudine) * No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin
References
Publications (1)
- BACKGROUNDLeighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18. PMID 21245868