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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PD Dr. med. Wolfgang Schuette
• Collaborators: Eli Lilly and Company; Roche Pharma AG
• Treatments: Bevacizumab; Carboplatin; Pemetrexed

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