Phase 2
Completed N=75
A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin
Source: ClinicalTrials.gov NCT01077739 ↗Enrolled (actual)
75
Serious AEs
40.0%
Results posted
Aug 2014
Primary outcomePrimary: Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression — 6.3; 5.1 months
Summary
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression |
6.3; 5.1 | — |
| SECONDARY PFS From the Start of First-Line Therapy |
17.8; 18.0 | — |
| SECONDARY Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR) |
27.3; 6.4 | — |
| SECONDARY Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression |
6.8; 6.1; 3.6; 4.2; 133.0; 186.0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >/=18 years of age
- metastatic colorectal cancer
- at least 1 measurable lesion according to RECIST v. 1.1
- patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
- disease progression 8 weeks after last Avastin administration
- clinically significant cardiovascular disease
- CNS disease except for treated brain metastasis
- history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
- major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
Data sourced from ClinicalTrials.gov (NCT01077739). 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.