Clinical trial · Interventional
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin Versus Oxaliplatin, Fluorouracil and Leucovorin Versus Bevacizumab Alone in Previously Treated Patients With Advanced Colorectal Cancer
- 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)
Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil)
- description
- Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
- interventionNames
- Biological: bevacizumab
- Drug: oxaliplatin
- Drug: leucovorin calcium
- Drug: fluorouracil
- type
- EXPERIMENTAL
- label
- Arm II (oxaliplatin, leucovorin calcium, fluorouracil)
- description
- Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I.
- interventionNames
- Drug: oxaliplatin
- Drug: leucovorin calcium
- Drug: fluorouracil
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the colon or rectum * Advanced or metastatic disease * Must have received a fluoropyrimidine-based regimen and an irinotecan-based regimen, either alone or in combination, for advanced disease * May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU) (or combination 5-FU and irinotecan) and progressed after single-agent irinotecan * Measurable disease * No known brain metastases * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of thrombotic or hemorrhagic disorders * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 5 times ULN * INR no greater than 1.5 * PTT no greater than ULN * Creatinine no greater than 1.5 times ULN * Proteinuria less than 1+ (i.e., 0 or trace) * Protein less than 500 mg by 24-hour urine collection * Proteinuria secondary to ureteral stents allowed * No proteinuria secondary to nephropathy * Controlled hypertension (less than 150/100 mm Hg) allowed if on a stable antihypertensive regimen * No prior myocardial infarction * No uncontrolled congestive heart failure * No unstable angina within the past 3 months * No serious nonhealing wound, ulcer, or bone fracture * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior bevacizumab * See Disease Characteristics * Recovered from prior chemotherapy * No prior oxaliplatin * At least 2 weeks since prior radiotherapy and recovered * At least 28 days since prior major surgical procedure * At least 10 days since prior aspirin dose of more than 325 mg/day * No concurrent therapeutic anticoagulation except prophylactic anticoagulation of venous access device * No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol) * No concurrent oral cryotherapy on day 1 of oxaliplatin administration
References
Publications (0)
Data not yet available