Clinical trial · Interventional
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
NCT00385021CI-TRIAL-00000948terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine efficacy in the delivery of chronomodulated chemotherapy.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil, leucovorin, oxaliplatin, avastin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 86 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proof of adenocarcinoma in primary colon or rectum tumor. * Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease. * Ages 18 to 86 years. * Presence of at least one bi-dimensionally measurable disease with at least one diameter \> or = 2 cm. * WHO/ECOG performance status \< 3 (0, 1, or 2) * Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted. * Signed informed consent Exclusion Criteria: * Peripheral sensory neuropathy \> or = grade 3. * Serum bilirubin (total) \> 3 X ULN. * Symptomatic or uncontrolled brain metastasis. * Metastases limited to bone, pleural effusion, or ascites. * Uncontrolled overt cardiac disease. * Uncontrolled hypercalcemia. * Uncontrolled infections. * Uncontrolled hypertension (\>180/110) * History of GI perforation. * History of arterial thromboembolic events. * History of congestive heart failure. * Patients taking warfarin (Coumadin). * Patients who are pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.