Clinical trial · Interventional
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
NCT02582970CI-TRIAL-00026352completedPhase 4Results postedClinicalTrials.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)
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
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 |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + Chemotherapy
- description
- Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Bevacizumab
- Drug: Irinotecan
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events
- timeFrame
- Baseline up to approximately 3 years
- description
- An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated metastatic colon or rectal cancer * Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment Exclusion Criteria: * Prior chemotherapy for metastatic colon or rectal cancer * Planned radiotherapy for underlying disease * Central nervous system metastases * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start * Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.