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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00621361
First received: February 12, 2008
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

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). [ Time Frame: From date of consent through to data cut-off, 7th August 2009. ] [ 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 [ Time Frame: From date of randomisation through to data cut-off, 7th August 2009. ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: February 2008
Study Completion Date: February 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00621361     History of Changes
Other Study ID Numbers: D8480C00054
Study First Received: February 12, 2008
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

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
 Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013