Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00768755

Purpose

AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung	Drug: axitinib Drug: chemotherapy	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess efficacy of axitinib given continuously in combination with pemetrexed/cisplatin in patients with non-squamous NSCLC compared to pemetrexed/cisplatin alone. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
To assess efficacy of axitinib given in a modified schedule in combination with pemetrexed/cisplatin in patients with non-squamous NSCLC compared to pemetrexed/cisplatin alone. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety of axitinib in combination with pemetrexed/cisplatin in patients with non-squamous NSCLC. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
To explore the severity of symptoms and the interference on various aspects of life as noted by patients in each treatment arm. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance	Drug: axitinib 5mg BID po up to max 10mg BID po
II: Experimental Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance	Drug: axitinib 5mg BID po up to max 10mg BID po paused for the duration of concomitant chemotherapy
III: Active Comparator pemetrexed and cisplatin	Drug: chemotherapy Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria:

Any histological/cytological evidence of predominantly squamous NSCLC.
Small cell or carcinoid lung cancer patients are also ineligible.
NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
Prior treatment with a VEGF or VEGFR inhibitor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768755

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Alabama
Pfizer Investigational Site
Huntsville, Alabama, United States, 35805
United States, Pennsylvania
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061039
Study First Received:	October 7, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00768755
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

non-squamous NSCLC, axitinib, pemetrexed/cisplatin

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

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

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009