Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00699491
First received: June 17, 2008
Last updated: May 5, 2015
Last verified: January 2015
Results First Received: May 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Biological: cixutumumab
Drug: temsirolimus
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dose Level 1
  • 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -1
  • 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2A
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2B
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Dose Level 1     Dose Level -1     Dose Level -2     Dose Level -2A     Dose Level -2B     Phase II  
STARTED     3     2     7     6     8     22  
COMPLETED     3     2     7     6     8     22  
NOT COMPLETED     0     0     0     0     0     0  



  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
Dose Level 1
  • 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -1
  • 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2A
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose Level -2B
  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level -1     Dose Level -2     Dose Level -2A     Dose Level -2B     Phase II     Total  
Number of Participants  
[units: participants]
  3     2     7     6     8     22     48  
Age  
[units: years]
Median (Full Range)
  35   (34 to 40)     68   (56 to 80)     49   (36 to 65)     53   (43 to 63)     48.5   (35 to 72)     57   (35 to 82)     48.5   (34 to 80)  
Gender  
[units: participants]
             
Female     3     2     7     6     8     22     48  
Male     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     3     2     7     6     8     22     48  



  Outcome Measures
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1.  Primary:   Recommended Dose Level for Phase II Testing (RPTD) (Phase I)   [ Time Frame: During first course ]

2.  Primary:   Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Duration of Response (Phase II)   [ Time Frame: Up to 5 years ]

5.  Secondary:   Progression Free Survival (PFS) (Phase II)   [ Time Frame: Time from registration to documentation of disease progression, up to 5 years ]

6.  Secondary:   Progression Free Survival Rate   [ Time Frame: At 6 months ]

7.  Secondary:   Survival Time (Phase II)   [ Time Frame: Time from registration to death due to any cause ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cynthia Ma, M.D., Ph.D.
Organization: Washington University School of Medicine
e-mail: cma@im.wustl.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00699491     History of Changes
Other Study ID Numbers: NCI-2009-00284, NCI-2009-00284, CDR0000598057, MC0736, 8129, P30CA015083, N01CM00099
Study First Received: June 17, 2008
Results First Received: May 5, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration