Clinical trial NCT01159171: A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Official title: Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>=18 years of age
* Locally advanced or metastatic colorectal cancer
* No previous treatment with chemotherapy for metastatic disease
* Measurable and/or evaluable lesions

Exclusion Criteria:

* Radiotherapy within 4 weeks before study
* Untreated brain metastases or primary brain tumors
* Chronic, daily treatment with high-dose aspirin (\>325mg/day)
* Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
measure: Percentage of Participants by Best Overall Response
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Secondary outcomes:
measure: Duration of Response - Percentage of Participants With an Event by 24 Months
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
measure: Duration of Response
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
measure: Duration of Stable Disease - Percentage of Participants With an Event by 24 Months
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
measure: Duration of Stable Disease
timeFrame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
measure: Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months
timeFrame: Baseline, every month to end of treatment (up to 24 months)
measure: Time to Treatment Failure
timeFrame: Baseline, monthly to end of study (up to 24 months)
measure: Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months
timeFrame: Baseline, monthly to end of study (up to 24 months)
measure: Time to Progression
timeFrame: Baseline, monthly to end of study (up to 24 months)
measure: Overall Survival (OS) - Percentage of Participants With an Event by 24 Months
timeFrame: Baseline, monthly to end of study (up to 24 months)
measure: Overall Survival
timeFrame: Baseline, monthly to end of study (up to 24 months)
Other outcomes:
Locations:
city: Aviano
country: Italy
city: Fano
country: Italy
city: Palermo
country: Italy
city: Rimini
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: