Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054028
First received: February 5, 2003
Last updated: March 3, 2015
Last verified: February 2015
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: suramin
Drug: paclitaxel
Other: pharmacological study

  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
Phase I trial was performed at Ohio State University(OSU). Phase II, OSU was the coordinating center with other participating centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women with metastatic breast cancer

Reporting Groups
  Description
Treatment (Suramin and Paclitaxel)

PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.


Participant Flow:   Overall Study
    Treatment (Suramin and Paclitaxel)  
STARTED     31  
Phase I     9  
Phase II     22  
COMPLETED     31  
NOT COMPLETED     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
Suramin and Paclitaxel (Phase I) Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
Suramin and Paclitaxel (Phase II) Patients receive paclitaxel in combination with the target dose of suramin.
Total Total of all reporting groups

Baseline Measures
    Suramin and Paclitaxel (Phase I)     Suramin and Paclitaxel (Phase II)     Total  
Number of Participants  
[units: participants]
  9     22     31  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 44 to 73 )  
  56  
  ( 35 to 70 )  
  56  
  ( 35 to 73 )  
Gender  
[units: participants]
     
Female     9     22     31  
Male     0     0     0  
Race (NIH/OMB)  
[units: patients]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     3     4  
White     8     19     27  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: patients]
     
United States     9     22     31  
ECOG performance status (PS) [1]
[units: patients]
     
ECOG PS 0     5     11     16  
ECOG PS 1     4     8     12  
ECOG PS 2     0     3     3  
Menopausal status  
[units: patients]
     
Premenopausal     0     1     1  
Postmenopausal     9     21     30  
ER/PR/HER 2 neu status  
[units: patients]
     
ER+ or PR+ Status     6     14     20  
HER2 neu+ Status     0     0     0  
Triple negative Status     3     8     11  
Number of sites of metastastic  
[units: patients]
     
1     1     9     10  
2     5     7     12  
≥3     3     6     9  
Sites of metastases  
[units: patients]
     
Liver     3     12     15  
Lung     6     10     16  
Bone     6     11     17  
Prior taxane therapy  
[units: patients]
     
Paclitaxel     4     9     13  
Docetaxel     5     10     15  
Nab-paclitaxel     0     1     1  
Paclitaxel and docetaxel     0     2     2  
Prior chemotherapy (metastatic setting)  
[units: patients]
     
0 Prior chemo therapies     5     0     5  
1 Prior chemo therapies     10     4     14  
2 Prior chemo therapies     7     3     10  
3 Prior chemo therapies     0     2     2  
[1]

0=Fully active, able to carry on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients That Achieved Target Suramin Concentrations in Plasma   [ Time Frame: Up to 5 years ]

2.  Primary:   Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)   [ Time Frame: Up to 8 weeks ]

3.  Secondary:   Response as Measured by RECIST Criteria   [ Time Frame: Up to 5 years ]


  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
No text entered.


  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: Maryam Lustberg, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-0066
e-mail: Maryam.Lustberg@osumc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054028     History of Changes
Other Study ID Numbers: NCI-2012-01431, 0216, OSU-02H0216, OSU-0216, NCI-5851, CDR0000269707, U01CA076576
Study First Received: February 5, 2003
Results First Received: November 17, 2014
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration