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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00621361

Purpose

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	Intervention	Phase
Lung Cancer	Drug: AZD2171 Drug: Etoposide Drug: Cisplatin	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etoposide Cisplatin Etoposide phosphate Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP). [ Designated as safety issue: Yes ]

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 [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD2171 Oral
2: Active Comparator Etoposide + Cisplatin	Drug: Etoposide Intravenous Drug: Cisplatin Intravenous

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621361

Contacts

Contact: AstraZeneca Clinical Study Information	+1-800-236-9933	information.center@astrazeneca.com
Contact: AZD2171 Trials		AZD2171trials@astrazeneca.com

Locations

United States, California
Research Site	Not yet recruiting
Sacramento, California, United States
United States, Colorado
Research Site	Not yet recruiting
Denver, Colorado, United States
United States, Kansas
Research Site	Recruiting
Kansas City, Kansas, United States
United States, Texas
Research Site	Recruiting
Houston, Texas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

John Heymach, MD

M.D. Anderson Cancer Center

More Information

Responsible Party:	AstraZeneca ( Nick Botwood / Medical Science Director )
Study ID Numbers:	D8480C00054
Study First Received:	February 12, 2008
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00621361
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Lung Cancer
AZD2171
cediranib

RECENTIN
etoposide
cisplatin

Study placed in the following topic categories:

Thoracic Neoplasms
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Neoplasm Metastasis
Etoposide phosphate
Etoposide

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009