Clinical trial NCT01077739: A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin
Official title: A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 dose of Avastin
* ECOG \</=2
* No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
timeFrame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Secondary outcomes:
measure: PFS From the Start of First-Line Therapy
timeFrame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
measure: Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
measure: Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
timeFrame: Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Arlon
country: Belgium
city: Assebroek
country: Belgium
city: AYE
country: Belgium
city: Bonheiden
country: Belgium
city: Brasschaat
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Dendermonde
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Kortrijk
country: Belgium
city: Mechelen
country: Belgium
city: Merksem
country: Belgium
city: Mont-godinne
country: Belgium
city: Montigny-le-Tilleul
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Sint-Niklaas
country: Belgium
city: Tournai
country: Belgium
city: Turnhout
country: Belgium
city: Verviers
country: Belgium
city: Wilrijk
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: