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

PD Dr. med. Wolfgang Schuette

Status and phase

Completed

Phase 3

Conditions

Non-squamous Non-small Cell Lung Cancer

Treatments

Drug: Bevacizumab + Pemetrexed + Carboplatin

Drug: Bevacizumab + Pemetrexed

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00976456

65 plus

ML21896

Details and patient eligibility

About

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

Full 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

Enrollment

271 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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