Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer - Full Text View

Purpose

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	Intervention	Phase
Non-squamous Non-small Cell Lung Cancer	Drug: Bevacizumab + Pemetrexed Drug: Bevacizumab + Pemetrexed + Carboplatin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Martha-Maria Krankenhaus Halle-Dölau gGmbH:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: 42 months ] [ Designated as safety issue: No ]
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:

Overall Survival [ Time Frame: 42 months ] [ Designated as safety issue: No ]
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).


Enrollment:	271
Study Start Date:	September 2009
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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: NCT00976456

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


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
Study First Received:	September 11, 2009
Results First Received:	January 12, 2016
Last Updated:	February 11, 2016
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Germany: Paul-Ehrlich-Institut Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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