Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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6 October 2015 |
Main ID: |
NCT02179567 |
Date of registration:
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30/06/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLC
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Scientific title:
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First Line Treatment of Elderly Patients With Advanced or Metastatic NSCLC With Docetaxel and Bevacizumab |
Date of first enrolment:
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March 2010 |
Target sample size:
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26 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT02179567 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Greece
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Contacts
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Name:
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Athanasios Karambeazis, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Medical Oncology Unit NIMTS (Veterans Hospital) |
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Name:
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Lambros Vamvakas, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Herklion |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =70 years old
- Cytologically or histologically documented NSCLC
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at
least one measurable lesion)
- World Health Organisation (WHO) performance status 0-2
- Non-frail patients according to Comprehensive Geriatric Assessment
- No prior chemotherapy
- Life expectancy of at least 12 weeks
- Serum bilirubin less than 1.5 times the upper normal limit
- Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper
normal limit in the absence of demonstrable liver metastases, or less than 5 times
the upper normal limit in the presence of liver metastases
- Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance
>60 ml/min
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
- Before patient enrollment, written informed consent must be given according to Good
Clinical Practice guidelines and national/local regulations.
Exclusion Criteria:
- Hemoptysis
- Central nervous system metastases
- Hemorrhagic diathesis or coagulopathy
- Anticoagulation therapy; regular use of aspirin (>325 mg/d), nonsteroidal
anti-inflammatory agents, or other agents known to inhibit platelet function
- Major surgery within 28 days before enrolment
- Clinically significant cardiovascular disease
- Medically uncontrolled hypertension
- Radiological evidence of tumors invading or abutting major blood vessels
- Other co-existing malignancies or malignancies diagnosed within the last 5 years
(with the exception of basal cell carcinoma or cervical cancer in situ)
- Any evidence of severe uncontrolled concomitant disease (in the opinion of the
investigator)
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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NSCLC
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Intervention(s)
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Drug: Bevacizumab
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Drug: Docetaxel
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Primary Outcome(s)
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Overall Response Rate
[Time Frame: Disease evaluation at Week 9]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: 1 year]
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Safety Profile
[Time Frame: Every three weeks up to 18 weeks]
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Progression Free Survival
[Time Frame: 1 year]
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Disease control rate
[Time Frame: Disease evaluation at Week 9]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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