Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors - Full Text View

Purpose

The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.

Condition	Intervention	Phase
Neoplasms	Drug: carboplatin + SU011248 (sunitinib) + paclitaxel	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel Carboplatin Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination. [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	November 2005
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: carboplatin + SU011248 (sunitinib) + paclitaxel AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity. Other Name: Paraplatin; SUTENT; Taxol

Arms

Assigned Interventions

Experimental: 1

Drug: carboplatin + SU011248 (sunitinib) + paclitaxel

AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.

Other Name: Paraplatin; SUTENT; Taxol

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent
Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens
ECOG performance status 0 or 1

Exclusion Criteria:

Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions
Diagnosis of any second malignancy within the past 3 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511849

Locations

United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Pfizer

Investigators

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00511849 History of Changes
Other Study ID Numbers:	A6181050
Study First Received:	August 3, 2007
Last Updated:	February 16, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Sunitinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013