Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive - Full Text View

Purpose

This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.

Condition	Intervention	Phase
Breast Cancer	Drug: Sunitinib Drug: Taxotere Drug: Herceptin	Phase I

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Docetaxel Sunitinib Sunitinib malate Trastuzumab

U.S. FDA Resources

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

Official Title:	An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety profile of the combination SU011248/docetaxel/trastuzumab [ Time Frame: From screening until 28 days post last dose of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine trough plasma concentrations (Ctrough) of SU011248 and its active metabolite SU012662, plasma concentrations of paclitaxel and serum concentrations of trastuzumab. [ Time Frame: From Cycle 1 Day 1 until Cycle 6 as per schedule of assessments ] [ Designated as safety issue: No ]
Preliminary activity (progression free survival, response rate, duration of response) of the combination SU011248/docetaxel/trastuzumab. [ Time Frame: From screening until disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	December 2006
Estimated Study Completion Date:	May 2009

Arms

Assigned Interventions

1: Experimental

Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)

Drug: Sunitinib

SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.

Drug: Taxotere

The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.

Drug: Herceptin

Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
Tumors over-expressing Her-2
Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

Histology of inflammatory carcinoma
AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372424

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


Belgium
	Pfizer Investigational Site	Recruiting
	Bruxelles, Belgium, 1200
	Pfizer Investigational Site	Recruiting
	Bruxelles, Belgium, 1000
	Pfizer Investigational Site	Recruiting
	Charleroi, Belgium, 6000
	Pfizer Investigational Site	Recruiting
	Wilrijk, Belgium, 2610

Italy
	Pfizer Investigational Site	Recruiting
	Milano, Italy, 20132

Italy, FC
	Pfizer Investigational Site	Recruiting
	Meldola, FC, Italy, 47014

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:	A6181113
First Received:	September 5, 2006
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00372424
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab.

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Sunitinib

Trastuzumab

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00372424