Clinical trial NCT00976456: Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: 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
Lead sponsor: Martha-Maria Krankenhaus Halle-Dölau gGmbH
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Eli Lilly and Company
First posted: 2009-09-14
Enrollment: 271
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 42 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 42 months
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau
Study officials:
affiliation: Krankenhaus Martha-Maria Halle-Doelau
name: Wolfgang Schuette, PhD MD.
role: STUDY_CHAIR
References: