Phase 3
Completed N=820
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Source: ClinicalTrials.gov NCT00700102 ↗Enrolled (actual)
820
Serious AEs
33.0%
Results posted
Jul 2015
Primary outcomePrimary: Overall Survival: Time From Randomization to Death From Any Cause — 9.8; 11.2 months — p=0.0062
Summary
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival: Time From Randomization to Death From Any Cause |
9.8; 11.2 | 0.0062 sig |
| SECONDARY Overall Survival: Months From Time of First Line Therapy |
22.5; 23.9 | 0.1713 |
| SECONDARY Participants With Progression Free Survival Event |
394; 386 | — |
| SECONDARY Progression Free Survival: Time to Event |
4.1; 5.7 | <.0001 sig |
| SECONDARY Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria |
3.9; 5.4 | 0.3113 |
| SECONDARY Response Rate: Participants With Response Status Based on RECIST Criteria |
0.5; 0.2; 3.4; 5.2; 50.2; 62.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >=18 years of age
- Metastatic colorectal cancer and disease progression
- Previously treated with first-line chemotherapy plus Avastin
- Eastern Cooperative Oncology Group (ECOG) performance status <=2.
Exclusion Criteria
- Diagnosis of progression of disease more than 3 months after last Avastin administration
- First-line patients with progression-free survival in first-line of <3 months
- Patients receiving less than 3 consecutive months of Avastin in first-line therapy
- Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
- Clinically significant cardiovascular disease within 6 months prior to start of study treatment
- Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
Data sourced from ClinicalTrials.gov (NCT00700102). 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.