Clinical trial NCT00700570: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer
Official title: An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 45
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \<=75 years of age;
* chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
* \>=1 measurable lesion;
* ECOG status 0-2.

Exclusion Criteria:

* prior exposure to Avastin;
* clinical or radiological evidence of CNS metastases;
* uncontrolled hypertension, or clinically significant cardiovascular disease;
* ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.

Primary outcomes:
measure: Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases
timeFrame: After 5 cycles of neoadjuvant treatment (10 weeks)
Secondary outcomes:
measure: Percentage of Participants With Disease Progression
timeFrame: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])
measure: Time to Disease Progression
timeFrame: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)
measure: Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1
timeFrame: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)
measure: Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1
timeFrame: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: