Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00054028
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 31
Recruitment Details Phase I trial was performed at Ohio State University(OSU). Phase II, OSU was the coordinating center with other participating centers.
Pre-assignment Details Women with metastatic breast cancer
Arm/Group Title Treatment (Suramin and Paclitaxel)
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 31
Phase I 9
Phase II 22
Completed 31
Not Completed 0
Arm/Group Title Suramin and Paclitaxel (Phase I) Suramin and Paclitaxel (Phase II) Total
Hide Arm/Group Description 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. Patients receive paclitaxel in combination with the target dose of suramin. Total of all reporting groups
Overall Number of Baseline Participants 9 22 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 22 participants 31 participants
56
(44 to 73)
56
(35 to 70)
56
(35 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 22 participants 31 participants
Female
9
 100.0%
22
 100.0%
31
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 22 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
3
  13.6%
4
  12.9%
White
8
  88.9%
19
  86.4%
27
  87.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
United States Number Analyzed 9 participants 22 participants 31 participants
9 22 31
ECOG performance status (PS)   [1] 
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
ECOG PS 0 5 11 16
ECOG PS 1 4 8 12
ECOG PS 2 0 3 3
[1]
Measure Description:

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.
Menopausal status  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
Premenopausal 0 1 1
Postmenopausal 9 21 30
ER/PR/HER 2 neu status  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
ER+ or PR+ Status 6 14 20
HER2 neu+ Status 0 0 0
Triple negative Status 3 8 11
Number of sites of metastastic  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
1 1 9 10
2 5 7 12
≥3 3 6 9
Sites of metastases  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
Liver 3 12 15
Lung 6 10 16
Bone 6 11 17
Prior taxane therapy  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
Paclitaxel 4 9 13
Docetaxel 5 10 15
Nab-paclitaxel 0 1 1
Paclitaxel and docetaxel 0 2 2
Prior chemotherapy (metastatic setting)  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 9 participants 22 participants 31 participants
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.Primary Outcome
Title Percentage of Patients That Achieved Target Suramin Concentrations in Plasma
Hide Description Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suramin and Paclitaxel
Hide Arm/Group Description:
Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percent of patients
88
2.Primary Outcome
Title Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)
Hide Description Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suramin and Paclitaxel
Hide Arm/Group Description:
Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: patients
Complete Response (CR) 0
Partial Response (PR) 5
3.Secondary Outcome
Title Response as Measured by RECIST Criteria
Hide Description Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Objective Response Rate
Arm/Group Title Treatment (Suramin and Paclitaxel)
Hide Arm/Group Description:
PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of patients
23
Time Frame All patients will be evaluable for toxicity using the NCI Common Toxicity Criteria version 3.0 from the time of their first treatment until the end of treatment.
Adverse Event Reporting Description The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
 
Arm/Group Title Suramin and Paclitaxel
Hide Arm/Group Description Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
All-Cause Mortality
Suramin and Paclitaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Suramin and Paclitaxel
Affected / at Risk (%) # Events
Total   1/31 (3.23%)    
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS)  1  1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Suramin and Paclitaxel
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  17/31 (54.84%)  17
Febrile neutropenia  1  1/31 (3.23%)  1
Endocrine disorders   
Renal insufficiency  1  5/31 (16.13%)  5
Gastrointestinal disorders   
Diarrhea  1  15/31 (48.39%)  15
Nausea  1  17/31 (54.84%)  17
Vomiting  1  9/31 (29.03%)  9
General disorders   
Fatigue (lethargy, malaise, asthenia)  1  30/31 (96.77%)  30
Immune system disorders   
Non-neutropenic fever  1  7/31 (22.58%)  7
Infections and infestations   
Infection without neutropenia  1  12/31 (38.71%)  12
Injury, poisoning and procedural complications   
Thrombocytopenia  1  2/31 (6.45%)  2
Investigations   
Leukocytes (total WBC)  1  14/31 (45.16%)  14
Lymphopenia  1  11/31 (35.48%)  11
Neutropenia  1  8/31 (25.81%)  8
Metabolism and nutrition disorders   
Anorexia  1  15/31 (48.39%)  15
Hypocalcemia  1  2/31 (6.45%)  2
Hypokalemia  1  3/31 (9.68%)  3
Hyponatremia  1  2/31 (6.45%)  2
Hypophosphatemia  1  1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia (joint pain)  1  14/31 (45.16%)  14
Myalgia (muscle pain)  1  14/31 (45.16%)  14
Nervous system disorders   
Neuropathy - motor  1  5/31 (16.13%)  5
Neuropathy-sensory  1  26/31 (83.87%)  26
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  12/31 (38.71%)  12
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  16/31 (51.61%)  16
Vascular disorders   
Thrombosis  1  2/31 (6.45%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maryam Lustberg, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-0066
EMail: Maryam.Lustberg@osumc.edu
Layout table for additonal information
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 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: November 17, 2014
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015