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

Non-squamous Non-small Cell Lung Cancer Clinical Trial

— 65plus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976456
• Other study ID #: 65 plus
• Secondary ID: ML21896
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2009
• Last updated: February 11, 2016
• Start date: September 2009
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: Martha-Maria Krankenhaus Halle-Dölau gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Paul-Ehrlich-InstitutGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-small Cell Lung Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Krankenhaus Martha-Maria Halle-Doelau	Halle

Sponsors (3)

Lead Sponsor	Collaborator
PD Dr. med. Wolfgang Schuette	Eli Lilly and Company, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	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).	42 months	No
Secondary	Overall Survival	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).	42 months	No