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Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer (65plus)

This study is ongoing, but not recruiting participants.
Sponsor:
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: November 12, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


Further study details as provided by Martha-Maria Krankenhaus Halle-Dölau gGmbH:

Primary Outcome Measures:
  • 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 [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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:
  • Avastin®
  • ALIMTA®
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:
  • Avastin®
  • ALIMTA®
  • Carboplatin

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Last Updated: November 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission

Keywords provided by 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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014