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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


Phase 3
65 Years
N/A
Open (Enrolling)
Both
Non-squamous Non-small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

42 months

Safety Issue:

No

Principal Investigator

Wolfgang Schuette, PhD MD.

Investigator Role:

Study Chair

Investigator Affiliation:

Krankenhaus Martha-Maria Halle-Doelau

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

65 plus

NCT ID:

NCT00976456

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Non-squamous Non-small Cell Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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