Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients

Study Overview
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Brief Summary
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This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.

Official Title
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A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: AZD2171
* Drug: Etoposide
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.) No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.) WHO performance status 0-2 Exclusion Criteria: Untreated unstable brain or meningeal metastases Patient with inappropriate laboratory tests values Inadequate bone marrow reserve.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD2171<br>* Oral<br>* Other names: Recentin™;|
| Active Comparator: 2<br>Etoposide + Cisplatin | Drug: Etoposide<br>* Intravenous<br>* Other names: Etopophos®;Drug: Cisplatin<br>* Intravenous<br>* Other names: Platinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP). |  | From date of consent through to data cut-off, 7th August 2009. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival |  | From date of randomisation through to data cut-off, 7th August 2009. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, AZD2171, cediranib, RECENTIN, etoposide, cisplatin