A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

NCT02582970 | Completed Phase 4 Results

• 1 other identifier: ML18436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events

  An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.

  Baseline up to approximately 3 years

Secondary Outcomes (6)

• Percentage of Participants Who Died

  Baseline up to approximately 3 years

• Duration of Survival

  Baseline up to approximately 3 years

• Percentage of Participants With Disease Progression or Death

  Baseline up to approximately 3 years

• Progression-Free Survival Time

  Baseline up to approximately 3 years

• Number of Participants With Best Overall Response

  Baseline up to approximately 3 years

Study Arms (1)

Bevacizumab + Chemotherapy

EXPERIMENTAL

Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Irinotecan; Drug: Oxaliplatin

Interventions

5-Fluorouracil DRUG

Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.

Bevacizumab + Chemotherapy

Bevacizumab DRUG

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

Also known as: Avastin

Bevacizumab + Chemotherapy

Irinotecan DRUG

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Bevacizumab + Chemotherapy

Oxaliplatin DRUG

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Bevacizumab + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated metastatic colon or rectal cancer
• Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

You may not qualify if:

• Prior chemotherapy for metastatic colon or rectal cancer
• Planned radiotherapy for underlying disease
• Central nervous system metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
• Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Chai Yi, 613, Taiwan

Location

Unknown Facility

Kaohsiung City, 00833, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taichung, 404, Taiwan

Location

Unknown Facility

Taichung, 407, Taiwan

Location

Unknown Facility

Tainan, 704, Taiwan

Location

Unknown Facility

Tainan, 710, Taiwan

Location

Unknown Facility

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; Bevacizumab; Irinotecan; 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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 21, 2015
• Study Start: May 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

TW (8)