Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00496275

Purpose

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Zactima (ZD6474) Drug: Vinorelbine plus cisplatin Drug: Gemcitabine plus cisplatin	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Vandetanib

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, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary Outcome Measures:

Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered [ Time Frame: Predetermined timepoints after dose administration ]
Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Enrollment:	17
Study Start Date:	August 2006
Study Completion Date:	October 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed non small cell lung cancer (stage IIIB-IV)
Life expectancy greater than 12 weeks
At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion Criteria:

Prior treatment with anticancer agent
Brain metastases
Major surgery within last 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496275

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Nick Thatcher, MD

Christie Hospitals NHS trust

More Information

Study ID Numbers:	D4200C00054
Study First Received:	July 3, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00496275
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

NSCLC
ZACTIMA

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009