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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00776698
First received: October 20, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single arm study will evaluate the feasibility of treatment with 2 dose lev els of Avastin in combination with concurrent thoracic radiation and chemotherap y in patients with locally advanced unresectable non-squamous non-small cell lun g 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 rece ive 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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: cisplatin
Drug: etoposide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, laboratory parameters [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
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).
Drug: cisplatin
80mg/m2 iv every 3 weeks for 3 cycles
Drug: etoposide
100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776698

Locations
Netherlands
Amsterdam, Netherlands, 1007 MB
Groningen, Netherlands, 9713 GZ
Maastricht, Netherlands, 6229 HX
United Kingdom
Aberdeen, United Kingdom, AB9 2ZB
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00776698     History of Changes
Other Study ID Numbers: BO21563, 2008-002279-28
Study First Received: October 20, 2008
Last Updated: August 4, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Cisplatin
Etoposide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014