Roche trials database

Trial information

A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

Status:

Completed

Protocol number:

ML18523

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin plus Capecitabine (XELOX) in Patients with Advanced Colorectal Cancer

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. Target sample size is 50.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Colorectal Cancer

Intervention type:

Drug

Intervention name:

bevacizumab [Avastin]

Primary outcome:

1. Overall response rate (ORR: complete and partial response); tumor assessments by Computer Tomography (CT) scan or by Magnetic Resonance Imaging (MRI) Time frame: 3.5 years

Key secondary outcomes:

1. Safety: Adverse events, laboratory parameters Time frame: 3.5 years
2. Duration of response (DR); tumor assessments by CT scan or ba MRI Time frame: from response to disease progression
3. Time to progression (TTP); tumor assessments by CT scan or by MRI Time frame: from baseline to disease progression
4. Overall Survival (OS) Time frame: from baseline to death of any cause

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

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

January, 2006

Trial registration date:

13.04.2006

Date last updated:

02.03.2012

This trial was conducted at the following locations:

Italy

• AVIANO
• FANO
• PALERMO
• RIMINI
• ROMA
• TORINO

Link to trial result