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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00621361
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : February 2008
Primary Completion Date : August 2009
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 [ Time Frame: From date of randomisation through to data cut-off, 7th August 2009. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621361


Locations
United States, California
Research Site
Sacramento, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Kansas
Research Site
Kansas City, Kansas, United States
United States, Texas
Research Site
Houston, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: John Heymach, MD M.D. Anderson Cancer Center
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00621361     History of Changes
Other Study ID Numbers: D8480C00054
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by AstraZeneca:
Lung Cancer
AZD2171
cediranib
RECENTIN
etoposide
cisplatin

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cediranib
Cisplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors