Phase 2
N=54
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01181609 ↗Enrolled (actual)
54
Serious AEs
17.0%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants Achieving Overall Disease Control (ODC) — 87 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Overall Disease Control (ODC) |
87 | — |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of CR or PR |
32 | — |
| SECONDARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
98 | — |
| SECONDARY PFS - Time to Event |
6.5 | — |
| SECONDARY Duration of Response |
6 | — |
| SECONDARY Duration of Overall Disease Control |
6.7 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
93.0 | — |
| SECONDARY OS - Time to Event |
19.3 | — |
Summary
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.
Eligibility Criteria
Inclusion Criteria
- Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
- Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.
Exclusion Criteria
- Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
- Untreated brain metastases, spinal cord compression or primary brain tumours;
- Pregnant or lactating women;
- 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 (NCT01181609). 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.