Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00616122
First received: February 14, 2008
Last updated: November 1, 2013
Last verified: November 2013
Results First Received: December 18, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: cyclophosphamide
Drug: methotrexate
Drug: sunitinib malate
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled on study between December 2006 and June 2010. Patients recruited in a medical clinic at the UCSF Helen Diller Family Comprehensive Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sunitinib, Cyclophosphamide, and Methotrexate Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).

Participant Flow:   Overall Study
    Sunitinib, Cyclophosphamide, and Methotrexate  
STARTED     32  
COMPLETED     25  
NOT COMPLETED     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sunitinib, Cyclophosphamide, and Methotrexate Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).

Baseline Measures
    Sunitinib, Cyclophosphamide, and Methotrexate  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 15  
Gender  
[units: participants]
 
Female     31  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (Phase I)   [ Time Frame: 8 weeks ]

2.  Primary:   PFS Greater Than or Equal to 12 Weeks (Phase II)   [ Time Frame: 12 weeks ]

3.  Secondary:   Response   [ Time Frame: until disease progression up to 13 months post treatment ]

4.  Secondary:   Duration of Response   [ Time Frame: until disease progression up to 13 months post treatment ]

5.  Secondary:   Correlation of Outcome Measures With Possible Surrogate Markers Including Serial Measurements of Circulating Tumor Cells and Circulating Endothelial Cells   [ Time Frame: until disease progression up to 13 months post treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Based on published literature indicating significant toxicity and low response rate for combination sunitinib in the treatment of advanced breast cancer, the PI and Breast Oncology Site Committee closed enrollment after accrual of 32 participants.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hope S. Rugo
Organization: UCSF Helen Diller Family Comprehensive Cancer Center
phone: 415-353-7618
e-mail: hrugo@medicine.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00616122     History of Changes
Other Study ID Numbers: CDR0000583268, UCSF-057519
Study First Received: February 14, 2008
Results First Received: December 18, 2012
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration