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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00621361

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: AZD2171 Drug: Etoposide Drug: Cisplatin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD2171 Oral Other Names: Recentin™
Active Comparator: 2 Etoposide + Cisplatin	Drug: Etoposide Intravenous Other Names: Etopophos® Drug: Cisplatin Intravenous Other Names: Platinol

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD2171

Oral

Other Names:

Recentin™

Active Comparator: 2

Etoposide + Cisplatin

Drug: Etoposide

Intravenous

Other Names:

Etopophos®

Drug: Cisplatin

Intravenous

Other Names:

Platinol

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Sacramento	California	United States
2	Research Site	Denver	Colorado	United States
3	Research Site	Kansas City	Kansas	United States
4	Research Site	Houston	Texas	United States