A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

NCT00700570 | Completed Phase 2 Results

• 1 other identifier: ML21209
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases

  Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as \[number of participants eligible for surgical resection divided by the number analyzed\] multiplied by 100.

  After 5 cycles of neoadjuvant treatment (10 weeks)

Secondary Outcomes (4)

• Percentage of Participants With Disease Progression

  Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])

• Time to Disease Progression

  Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)

• Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1

  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)

• Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1

  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)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: oxaliplatin

Interventions

bevacizumab [Avastin] DRUG

5mg/kg iv on day 1 of each 2 week cycle.

1

capecitabine [Xeloda] DRUG

1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle

1

oxaliplatin DRUG

85mg/m2 iv on day 1 of each 2 week cycle

1

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Kaohsiung City, 00833, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taichung, 407, Taiwan

Location

Unknown Facility

Taipei, 00112, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

Unknown Facility

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016
• Results First Posted: October 1, 2015

Record last verified: 2016-11

Locations

TW (6)