Phase 2
Completed N=306
A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Source: ClinicalTrials.gov NCT01131078 ↗Enrolled (actual)
306
Serious AEs
26.3%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 86.14; 90.20; 88.35 percentage of participants
Summary
A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death |
86.14; 90.20; 88.35 | — |
| PRIMARY Time to Progression (TTP) |
8.35; 8.15; 7.27 | — |
| SECONDARY Percentage of Participants Who Died |
67.33; 71.57; 73.79 | — |
| SECONDARY Overall Survival |
22.75; 19.76; 18.02 | — |
| SECONDARY Percentage of Participants With Treatment Failure |
100.0; 99.02; 99.03 | — |
| SECONDARY Time to Treatment Failure |
6.67; 6.87; 5.75 | — |
| SECONDARY Percentage of Participants With Progression Excluding Deaths |
71.29; 81.37; 75.73 | — |
| SECONDARY Time to Progression Excluding Deaths |
8.81; 8.48; 7.40 | — |
| SECONDARY Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer |
81.19; 90.20; 85.44 | — |
| SECONDARY Time to Progression Excluding Deaths Not Related to Underlying Cancer |
8.68; 8.32; 7.27 | — |
| SECONDARY Percentage of Participants by Best Overall Response |
5.49; 1.09; 5.32; 46.15; 32.61; 28.72 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of CR or PR |
52.0; 34.0; 34.0 | — |
| SECONDARY Percentage of Participants With Stable Disease |
91.0; 86.0; 80.0 | — |
| SECONDARY Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment |
9.0; 13.0; 18.0 | — |
| SECONDARY Duration of Overall Response |
6.51; 6.61; 9.12 | — |
| SECONDARY Duration of Stable Disease (SD) |
8.81; 8.65; 8.98 | — |
| SECONDARY Duration of Overall Complete Response |
8.35; 6.05; 12.89 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- colon or rectal cancer, with metastases;
- >=1 measurable lesion.
Exclusion Criteria
- previous systemic treatment for advanced disease;
- radiotherapy to any site within 4 weeks before study;
- daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
- co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
Data sourced from ClinicalTrials.gov (NCT01131078). 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.