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Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer (65plus)
This study has been completed.
Sponsor:
PD Dr. med. Wolfgang Schuette
Collaborators:
Roche Pharma AG
Eli Lilly and Company
Information provided by (Responsible Party):
PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH
ClinicalTrials.gov Identifier:
NCT00976456
First received: September 11, 2009
Last updated: February 11, 2016
Last verified: February 2016
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Non-squamous Non-small Cell Lung Cancer | Drug: Bevacizumab + Pemetrexed Drug: Bevacizumab + Pemetrexed + Carboplatin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 42 months ]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).
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 42 months ]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).
| Enrollment: | 271 |
| Study Start Date: | September 2009 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed
|
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
Other Names:
|
|
Active Comparator: Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin
|
Drug: 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
Other Names:
|
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| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00976456
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976456
Locations
| Germany | |
| Krankenhaus Martha-Maria Halle-Doelau | |
| Halle, Germany, 06120 | |
Sponsors and Collaborators
PD Dr. med. Wolfgang Schuette
Roche Pharma AG
Eli Lilly and Company
Investigators
| Study Chair: | Wolfgang Schuette, PhD MD. | Krankenhaus Martha-Maria Halle-Doelau |
More Information
| Responsible Party: | PD Dr. med. Wolfgang Schuette, PhD MD, Martha-Maria Krankenhaus Halle-Dölau gGmbH |
| ClinicalTrials.gov Identifier: | NCT00976456 History of Changes |
| Other Study ID Numbers: |
65 plus ML21896 |
| Study First Received: | September 11, 2009 |
| Results First Received: | January 12, 2016 |
| Last Updated: | February 11, 2016 |
Keywords provided by PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH:
|
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 |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Bevacizumab Carboplatin |
Pemetrexed Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017