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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: November 3, 2014
Last verified: November 2014

October 20, 2008
November 3, 2014
April 2009
February 2010   (final data collection date for primary outcome measure)
Dose limiting toxicity [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776698 on ClinicalTrials.gov Archive Site
  • AEs, laboratory parameters [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: cisplatin
  • Drug: etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00776698
BO21563, 2008-002279-28
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP