A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors - Full Text View

Purpose

This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer Mesothelioma Neoplasms	Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin	Phase I

MedlinePlus related topics:

Cancer Lung Cancer Mesothelioma

Drug Information available for:

Carboplatin Cisplatin Sunitinib Sunitinib malate Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin. [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered. [ Time Frame: From screening until disease progression or discontinuation of the study ] [ Designated as safety issue: No ]
To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma. [ Time Frame: From screening until disease progression or discontinuation of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2006
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
A: Experimental	Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
Patient has a good performance status (ECOG 0 or 1).

Exclusion Criteria:

Prior treatment with either pemetrexed or SU011248.
Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
Hypertension that cannot be controlled by medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528619

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, Colorado
	Pfizer Investigational Site	Recruiting
	Aurora, Colorado, United States, 80012
	Pfizer Investigational Site	Recruiting
	Aurora, Colorado, United States, 80045
	Pfizer Investigational Site	Recruiting
	Denver, Colorado, United States, 80218

Canada, Ontario
	Pfizer Investigational Site	Recruiting
	Ottawa, Ontario, Canada, K1H 8L6

Canada, Quebec
	Pfizer Investigational Site	Recruiting
	Montreal, Quebec, Canada, H2L 4M1

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:	A6181084
First Received:	September 10, 2007
Last Updated:	November 1, 2008
ClinicalTrials.gov Identifier:	NCT00528619
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Solid tumor malignancy, non-small cell lung cancer, sunitinib, pemetrexed, Phase 1

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Carboplatin

Carcinoma

Folic Acid

Pemetrexed

Cisplatin

Respiratory Tract Diseases

Lung Neoplasms

Sunitinib

Lung Diseases

Mesothelioma

Carcinoma, Non-Small-Cell Lung

Adenoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Neoplasms, Mesothelial

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Folic Acid Antagonists

Angiogenesis Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

Growth Inhibitors

Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00528619