Phase 3
Completed N=162
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
Source: ClinicalTrials.gov NCT01169558 ↗Enrolled (actual)
162
Serious AEs
30.9%
Results posted
Oct 2016
Primary outcomePrimary: Safety: Number of Participants With Serious and Specific Adverse Events — 50; 57; 42; 22 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With Serious and Specific Adverse Events |
50; 57; 42; 22; 6; 5 | — |
| SECONDARY Efficacy: Overall Survival |
21.6 | — |
| SECONDARY Efficacy: Time to Disease Progression |
11.4 | — |
| SECONDARY Efficacy: Progression-free Survival |
11.0 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated metastatic colon or rectal cancer;
- Scheduled to begin fluoropyrimidine-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 before study start.
Data sourced from ClinicalTrials.gov (NCT01169558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.