A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.

NCT00773188 | Completed Phase 1

• 1 other identifier: BO21247
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.

  Throughout study

Secondary Outcomes (1)

• Tumor response

  Week 13 and Week 22

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: cisplatin; Drug: vinorelbine

Interventions

bevacizumab [Avastin] DRUG

7.5mg/kg iv or 15mg/kg iv every 3 weeks

1

cisplatin DRUG

75mg/m2 iv according to a standard chemotherapy treatment protocol

1

vinorelbine DRUG

15mg/m2 iv according to a standard chemotherapy treatment protocol

1

Eligibility Criteria

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

You may qualify if:

• patients \>=18 years with locoregional advanced unresectable non-squamous NSCLC;
• ECOG performance status of 0 or 1;
• no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

You may not qualify if:

• mixed, non-small cell and small cell tumors;
• mixed adeno-squamous carcinomas with a predominant squamous component;
• evidence of tumor invasion or encasement of major vessels;
• history of grade \>=2 hemoptysis;
• presence of cavitations in lung lesions at baseline.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Calgary, Alberta, T2N 4N2, Canada

Location

Unknown Facility

Oshawa, Ontario, L1G 2B9, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Bevacizumab; Cisplatin; Vinorelbine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (4)