A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

NCT00577109 | Withdrawn Phase 2

• 1 other identifier: ML20452
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  12 months

Secondary Outcomes (2)

• Objective response rate, rate of resection of hepatic metastases, overall survival.

  Event driven

• AEs, laboratory parameters.

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: Irinotecan; Drug: Leucovorin; Drug: 5 FU; Drug: Cetuximab

Interventions

bevacizumab [Avastin] DRUG

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

1

Irinotecan DRUG

180mg/m2 iv on day 1 of each 2 week cycle

1

Leucovorin DRUG

200mg/m2 iv on day 1 of each 2 week cycle

1

5 FU DRUG

400mg/m2 iv on day 1 of each 2 week cycle

1

Cetuximab DRUG

Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

1

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• colorectal cancer;
• advanced or recurrent disease;
• \>=1 measurable lesion;
• \>=6 months since prior adjuvant therapy, and \>=4 weeks since prior radiotherapy.

You may not qualify if:

• previous treatment for colorectal cancer;
• significant history of cardiac disease in past 6 months;
• other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (3)

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Sorocaba, Brazil

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Irinotecan; Leucovorin; Cetuximab

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; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 31, 2018

Record last verified: 2016-08

Locations

BR (3)