A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01077713
First received: February 9, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: gemcitabine
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Tumor assessments at each clinic visit for 6 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout study for 6 months ] [ Designated as safety issue: No ]
  • Laboratory parameters [ Time Frame: At each clinic visit for 6 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Tumor assessments at each clinic visit for 6 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: February 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Drug: gemcitabine
1200mg/m2 on days 1-8 of each 3 week cycle
Experimental: 2 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Drug: gemcitabine
1000mg/m2 on days 1-8 of each 3 week cycle
Drug: cisplatin
60mg/m2 on day 1 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=70 years of age;
  • inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
  • >=1 measurable lesion;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
  • radical radiotherapy with curative intent within 28 days prior to enrollment;
  • history of >=grade 2 hemoptysis in 3 months prior to enrollment;
  • evidence of CNS metastases;
  • current or recent (within 10 days of first dose of Avastin)use of aspirin (>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077713

Locations
Italy
Rionero in Vulture, Basilicata, Italy, 85028
Catanzaro, Calabria, Italy, 88100
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40139
Aviano, Friuli-Venezia Giulia, Italy, 33081
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00189
Roma, Lazio, Italy, 00128
Viterbo, Lazio, Italy, 01100
Genova, Liguria, Italy, 16149
Bergamo, Lombardia, Italy, 24128
Milano, Lombardia, Italy, 20142
Monza, Lombardia, Italy, 20052
Rho, Lombardia, Italy, 20017
Sondalo, Lombardia, Italy, 23039
Sondrio, Lombardia, Italy, 23100
Ancona, Marche, Italy, 60121
Pesaro, Marche, Italy, 61122
Novara, Piemonte, Italy, 28100
Catania, Sicilia, Italy, 95100
Lido Di Camaiore, Toscana, Italy, 55043
Perugia, Umbria, Italy, 06156
Mirano, Veneto, Italy, 30035
Padova, Veneto, Italy, 35128
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: NCT01077713     History of Changes
Other Study ID Numbers: ML21868, 2008-008739-27
Study First Received: February 9, 2010
Last Updated: April 14, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014