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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


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
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