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

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Drug: AZD2171; Drug: Etoposide; Drug: Cisplatin

• Registration Number: NCT00621361
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Primary Completion: 2009-08
• Study Completion: 2012-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• Untreated unstable brain or meningeal metastases
• Patient with inappropriate laboratory tests values
• Inadequate bone marrow reserve.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD2171	-
2	Etoposide	Etoposide + Cisplatin
2	Cisplatin	Etoposide + Cisplatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States