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

Primary Purpose

Non-squamous Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed + Carboplatin

About this trial

This is an interventional treatment trial for Non-squamous Non-small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Krankenhaus Martha-Maria Halle-Doelau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed + Carboplatin

Arm Description

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed + Carboplatin

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Overall Survival

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).

Full Information

NCT ID

NCT00976456

First Posted

September 11, 2009

Last Updated

February 11, 2016

Sponsor

PD Dr. med. Wolfgang Schuette

Collaborators

Roche Pharma AG, Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00976456

Brief Title

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

Acronym

65plus

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

PD Dr. med. Wolfgang Schuette

Collaborators

Roche Pharma AG, Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

271 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab + Pemetrexed

Arm Type

Active Comparator

Arm Description

Bevacizumab + Pemetrexed

Arm Title

Bevacizumab + Pemetrexed + Carboplatin

Arm Type

Active Comparator

Arm Description

Bevacizumab + Pemetrexed + Carboplatin

Intervention Type

Drug

Intervention Name(s)

Bevacizumab + Pemetrexed

Other Intervention Name(s)

Avastin®, ALIMTA®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bevacizumab + Pemetrexed + Carboplatin

Other Intervention Name(s)

Avastin®, ALIMTA®, Carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Time Frame

42 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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).

Time Frame

42 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Schuette, PhD MD.

Organizational Affiliation

Krankenhaus Martha-Maria Halle-Doelau

Official's Role

Study Chair

Facility Information:

Facility Name

Krankenhaus Martha-Maria Halle-Doelau

City

Halle

ZIP/Postal Code

06120

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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