Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174434
First received: September 12, 2005
Last updated: January 26, 2009
Last verified: October 2008
  Purpose

This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Condition Intervention Phase
Breast Neoplasms
Drug: SU011248
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety of the combination of SU011248 and paclitaxel [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of each medication [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]
  • Objective disease response [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]
  • Progression-free survival. [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: SU011248
SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
Other Name: sunitinib malate, Sutent
Drug: Paclitaxel
Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.

  Eligibility

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

Inclusion Criteria:

  • Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
  • Candidate for treatment with paclitaxel.

Exclusion Criteria:

  • Prior chemotherapy in the advanced disease setting.
  • HER2 positive disease unless previously treated with trastuzumab.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174434

Locations
United States, Illinois
Pfizer Investigational Site
Harvey, Illinois, United States, 60426
Pfizer Investigational Site
Harvey, Illinois, United States, 60426-4265
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46290
Pfizer Investigational Site
Munster, Indiana, United States, 46321
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00174434     History of Changes
Other Study ID Numbers: A6181073
Study First Received: September 12, 2005
Last Updated: January 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Sunitinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014