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OpenTrials
Completed

NCT Number: NCT00976456

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

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

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Krankenhaus Martha-Maria Halle-Doelau

Halle, 06120, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Avastin®, ALIMTA®

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

Other names: Avastin®, ALIMTA®, Carboplatin

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

PD Dr. med. Wolfgang Schuette

Other

Collaborators

  • Eli Lilly and Company
  • Roche Pharma AG

Registry information

Official study 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

Acronym: 65plus

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2009
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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