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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621361
• Other study ID #: D8480C00054
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2008
• Last updated: December 13, 2012
• Start date: February 2008
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• AZD2171
Oral
• Etoposide
Intravenous
• Cisplatin
Intravenous

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Kansas
United States	Research Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No

External Links

•   Cancer Study Locator (US and Canada only)