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Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer (65plus)

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ClinicalTrials.gov Identifier: NCT00976456
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborators:
Roche Pharma AG
Eli Lilly and Company
Information provided by (Responsible Party):
PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH

Study Description
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Brief Summary:

Multi-center, open, randomized (parallel) and comparative phase III.

Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

Arm A: Bevacizumab + pemetrexed

Arm B: Bevacizumab + pemetrexed + carboplatin


Condition or disease Intervention/treatment Phase
Non-squamous Non-small Cell Lung Cancer Drug: Bevacizumab + Pemetrexed Drug: Bevacizumab + Pemetrexed + Carboplatin Phase 3

Detailed Description:

Primary:

  • Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival

Secondary:

  • To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
  • To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
  • To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
  • To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
  • To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Study Start Date : September 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed
 Drug: Bevacizumab + Pemetrexed
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
Other Names:
  • Avastin®
  • ALIMTA®
Active Comparator: Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin
 Drug: Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Other Names:
  • Avastin®
  • ALIMTA®
  • Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 42 months ]
    Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 42 months ]
    Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
  • Age ≥ 65 years
  • ECOG 0-2

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
  • History of haemoptysis
  • Evidence of tumour invading major blood vessels on imaging
  • Radiotherapy within 28 days prior to enrolment
  • Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
  • Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
  • Non-healing wound, active peptic ulcer or bone fracture
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976456


Locations
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Germany
Krankenhaus Martha-Maria Halle-Doelau
Halle, Germany, 06120
Sponsors and Collaborators
PD Dr. med. Wolfgang Schuette
Roche Pharma AG
Eli Lilly and Company
Investigators
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Study Chair: Wolfgang Schuette, PhD MD. Krankenhaus Martha-Maria Halle-Doelau
More Information
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Responsible Party: PD Dr. med. Wolfgang Schuette, PhD MD, Martha-Maria Krankenhaus Halle-Dölau gGmbH
ClinicalTrials.gov Identifier: NCT00976456    
Other Study ID Numbers: 65 plus
ML21896
First Posted: September 14, 2009    Key Record Dates
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016
Last Verified: February 2016
Keywords provided by PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH:
lung cancer
NSCLC
elderly
non-squamous
 Elderly patients at least 65 years old
first line therapy
non-squamous non-small cell lung cancer stage IIIb or IV
Additional relevant MeSH terms:
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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
Carboplatin
 Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors