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

NCT00976456 | Completed Phase 3 Results DMC

• 2 other identifiers: 65 plusML21896
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall Survival

  42 months

Study Arms (2)

Bevacizumab + Pemetrexed

ACTIVE COMPARATOR

Bevacizumab + Pemetrexed

Drug: Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed + Carboplatin

ACTIVE COMPARATOR

Bevacizumab + Pemetrexed + Carboplatin

Drug: Bevacizumab + Pemetrexed + Carboplatin

Interventions

Bevacizumab + Pemetrexed DRUG

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

Also known as: Avastin®, ALIMTA®

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed + Carboplatin DRUG

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

Also known as: Avastin®, ALIMTA®, Carboplatin

Bevacizumab + Pemetrexed + Carboplatin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
• Age ≥ 65 years
• ECOG 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. med. Wolfgang Schuette: lead
• Roche Pharma AG: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Krankenhaus Martha-Maria Halle-Doelau

Halle, 06120, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bevacizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Prof. Dr. Wolfgang Schuette
• Organization: Krankenhaus Martha-Maria Halle-Doelau gGmbH

wolfgang.schuette@martha-maria.de

+49 345 5591440

Study Officials

• Wolfgang Schuette, PhD MD.

  Krankenhaus Martha-Maria Halle-Doelau

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 10, 2016
• Results First Posted: March 10, 2016

Record last verified: 2016-02

Locations

DE (1)