Phase 4
Completed N=40
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
Source: ClinicalTrials.gov NCT02582970 ↗Enrolled (actual)
40
Serious AEs
35.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Adverse Events — 100 percentage of 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 This can indicate results are unpublished — a known publication-bias signal.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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
100 | — |
| SECONDARY Percentage of Participants Who Died |
62.5 | — |
| SECONDARY Duration of Survival |
23.8 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death |
85.0 | — |
| SECONDARY Progression-Free Survival Time |
12.2 | — |
| SECONDARY Number of Participants With Best Overall Response |
2; 19; 8; 9; 2 | — |
| SECONDARY Mean Direct Medical Cost for Cancer Related Medical Care Utilization |
0.91; 35.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02582970). 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.