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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Study Chair:	Wolfgang Schuette, PhD MD.	Krankenhaus Martha-Maria Halle-Doelau

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	PD Dr. med. Wolfgang Schuette, PhD MD, Martha-Maria Krankenhaus Halle-Dölau gGmbH
ClinicalTrials.gov Identifier:	NCT00976456 History of Changes
Other Study ID Numbers:	65 plus; ML21896
First Posted:	September 14, 2009
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:

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; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors