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

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ClinicalTrials.gov Identifier: NCT00528619

Recruitment Status : Completed

First Posted : September 12, 2007

Last Update Posted : April 8, 2011

Sponsor:

Information provided by:

Pfizer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Neoplasms	Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	96 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
Study Start Date :	November 2006
Actual Primary Completion Date :	April 2010
Actual Study Completion Date :	April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin Carboplatin Pemetrexed Pemetrexed disodium Sunitinib malate Sunitinib

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: A	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. Other Name: Sutent, SU011248, Alimta, Platinol, Paraplatin

Outcome Measures

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 ]

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 ]
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 ]

Eligibility Criteria

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

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): NCT00528619

Locations

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United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
Canada, Ontario
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

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

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Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00528619
Other Study ID Numbers:	A6181084
First Posted:	September 12, 2007 Key Record Dates
Last Update Posted:	April 8, 2011
Last Verified:	April 2011

Keywords provided by Pfizer:


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

Additional relevant MeSH terms:

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Cisplatin Carboplatin Pemetrexed Sunitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists	Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors

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