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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01077713
First received: February 9, 2010
Last updated: October 6, 2014
Last verified: October 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 treatm ent in elderly patients with non-squamous non-small cell lung cancer. Patients w ill be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1 200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cis platin 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 A vastin monotherapy. The anticipated time on study treatment is until disease pro gression, and the target sample size is <100 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: cisplatin
Drug: gemcitabine
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
Study Completion Date: July 2014
Primary Completion Date: July 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: cisplatin
60mg/m2 on day 1 of each 3 week cycle
Drug: gemcitabine
1000mg/m2 on days 1-8 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
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: 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: October 6, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014