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

Information source: Martha-Maria Krankenhaus Halle-Dlau gGmbH
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-squamous Non-small Cell Lung Cancer

Intervention: Bevacizumab + Pemetrexed (Drug); Bevacizumab + Pemetrexed + Carboplatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: PD Dr. med. Wolfgang Schuette

Official(s) and/or principal investigator(s):
Wolfgang Schuette, PhD MD., Study Chair, Affiliation: Krankenhaus Martha-Maria Halle-Doelau

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

Clinical Details

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

Primary outcome: Efficacy of a monochemotherapy pemetrexed + bevacizumab versus a combination chemotherapy of pemetrexed + carboplatin + bevacizumab in elderly patients (> 65 years) as 1st-line treatment of advanced metastatic or recurrent non-squamous NSCLC by PSF

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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Krankenhaus Martha-Maria Halle-Doelau, Halle 06120, Germany
Additional Information

Starting date: September 2009
Last updated: April 8, 2015

Page last updated: August 20, 2015

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