Clinical trial · Interventional
MRI in Predicting Response in Patients Receiving Combination Chemotherapy and Bevacizumab For Advanced or Metastatic Colorectal Cancer
A Phase II Study Assessing Tumor Blood Flow as Measured by Dynamic Contrast Enhanced MRI in Patients With Metastatic Colorectal Cancer Receiving FOLFOX Alone Versus Patients Randomized to Receive FOLFOX Plus Bevacizumab at 5mg/kg or 10mg/kg.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, 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 bevacizumab together with combination chemotherapy may kill more tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying how well MRI works in predicting response to combination chemotherapy given together with bevacizumab in treating patients with advanced or metastatic 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 (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
- description
- Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours (FOLFOX) beginning on day 1. Patients also receive bevacizumab at 5 mg/kg IV over 90 minutes on day 1. Treatment repeats every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: bevacizumab
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive FOLFOX as in arm I and bevacizumab at 10 mg/kg IV over 90 minutes on day 1. Treatment repeats every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: bevacizumab
- Drug: fluorouracil
- Drug: leucovorin calcium
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum * Patients receiving bevacizumab must have tumor tissue available for immunohistochemical analysis * Formalin-fixed, paraffin-embedded tissue from previous biopsy or surgical resection is sufficient * Measurable disease, defined by RECIST as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques (i.e., CT or MRI) * CEA elevation alone is insufficient for study entry * No known brain metastases PATIENT CHARACTERISTICS: Criteria for all patients * ECOG performance status 0-1 * Life expectancy \> 3 months * Granulocytes ≥ 1,500/mL * Platelet Count ≥ 100,000/mL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST ≤ 5 times ULN * Urine protein:creatinine ratio ≤ 1.0 at screening * Patients with other prior malignancies are eligible, provided they have been treated with curative intent and have no evidence of recurrence * Not pregnant or nursing * Negative pregnancy test * No contraindications to MRI, including any of the following: * Hypersensitivity to gadolinium * Metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI-compatible mechanical and/or electrical device, or metallic fragments * Severe claustrophobia Additional criteria for patients receiving bevacizumab: * No significant traumatic injury within the past 28 days * No serious nonhealing wounds, ulcers, or bone fractures * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No myocardial infarction, unstable angina, or cerebrovascular accident within the past 6 months * No clinically significant peripheral vascular disease * No New York Heart Association class II-IV congestive heart failure * Patients with pre-existing hypertension should be on a stable antihypertensive regimen with blood pressure ≤ 150/100 mm Hg at study entry PRIOR CONCURRENT THERAPY: Criteria for all patients * Prior adjuvant treatment including oxaliplatin allowed * No prior bevacizumab * At least 14 days since prior radiotherapy and recovered * More than 6 months since prior chemotherapy * No other concurrent investigational agents Additional criteria for patients receiving bevacizumab: * At least 28 days since prior major surgical procedure or open biopsy * At least 7 days since prior minor surgical procedure (e.g., fine-needle aspirations or core biopsies) * No anticipation of need for a major surgical procedure during study treatment * Concurrent oral or parenteral anticoagulation therapy allowed provided dose is stable
References
Publications (0)
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