A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.

NCT00776698 | Completed Phase 1

• 2 other identifiers: BO215632008-002279-28
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 5

Brief Summary

This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is \<3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is \<100 individuals.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  Throughout Study

Secondary Outcomes (2)

• AEs, laboratory parameters

  Throughout Study

• Tumor response

  Throughout Study

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

bevacizumab [Avastin] DRUG

7.5mg/kg every 3 weeks for 3 cycles (cohort 1) or 15mg/kg every 3 weeks for 3 cycles (cohort 2). Preferred dose every 3 weeks for 9 cycles (cohort 3).

1

cisplatin DRUG

80mg/m2 iv every 3 weeks for 3 cycles

1

etoposide DRUG

100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

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;
• non-squamous non-small cell lung cancer, locally advanced and unresectable;
• ECOG performance status 0 or 1;
• no prior thoracic or head and neck radiation;
• no prior surgical resection for current lung cancer.

You may not qualify if:

• prior systemic therapy for non-small cell lung cancer;
• clinically significant cardiovascular disease;
• history of \>= grade 2 hemoptysis;
• current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Amsterdam, 1007 MB, Netherlands

Location

Unknown Facility

Groningen, 9713 GZ, Netherlands

Location

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

Unknown Facility

Aberdeen, AB9 2ZB, United Kingdom

Location

Unknown Facility

Manchester, M2O 4BX, United Kingdom

Location

MeSH Terms

Interventions

Bevacizumab; Cisplatin; Etoposide

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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

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 20, 2008
• First Posted: October 21, 2008
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (2); NL (3)