Phase 2
N=306
A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01131078 ↗Enrolled (actual)
306
Serious AEs
26.3%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Participants With Disease Progression or Death — 86.14; 90.20; 88.35 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab [Avastin] (Drug); Capecitabine (Drug); Irinotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2012
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 | — |
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.
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.