Trial Outcomes & Findings for Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer (NCT NCT00054028)
NCT ID: NCT00054028
Last Updated: 2015-03-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2015-03-17
Participant Flow
Phase I trial was performed at Ohio State University(OSU). Phase II, OSU was the coordinating center with other participating centers.
Women with metastatic breast cancer
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
Phase I
|
9
|
|
Overall Study
Phase II
|
22
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Suramin and Paclitaxel (Phase I)
n=9 Participants
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)
n=22 Participants
Patients receive paclitaxel in combination with the target dose of suramin.
|
Total
n=31 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 patients
n=5 Participants
|
22 patients
n=7 Participants
|
31 patients
n=5 Participants
|
|
ECOG performance status (PS)
ECOG PS 0
|
5 patients
n=5 Participants
|
11 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
ECOG performance status (PS)
ECOG PS 1
|
4 patients
n=5 Participants
|
8 patients
n=7 Participants
|
12 patients
n=5 Participants
|
|
ECOG performance status (PS)
ECOG PS 2
|
0 patients
n=5 Participants
|
3 patients
n=7 Participants
|
3 patients
n=5 Participants
|
|
Menopausal status
Premenopausal
|
0 patients
n=5 Participants
|
1 patients
n=7 Participants
|
1 patients
n=5 Participants
|
|
Menopausal status
Postmenopausal
|
9 patients
n=5 Participants
|
21 patients
n=7 Participants
|
30 patients
n=5 Participants
|
|
ER/PR/HER 2 neu status
ER+ or PR+ Status
|
6 patients
n=5 Participants
|
14 patients
n=7 Participants
|
20 patients
n=5 Participants
|
|
ER/PR/HER 2 neu status
HER2 neu+ Status
|
0 patients
n=5 Participants
|
0 patients
n=7 Participants
|
0 patients
n=5 Participants
|
|
ER/PR/HER 2 neu status
Triple negative Status
|
3 patients
n=5 Participants
|
8 patients
n=7 Participants
|
11 patients
n=5 Participants
|
|
Number of sites of metastastic
1
|
1 patients
n=5 Participants
|
9 patients
n=7 Participants
|
10 patients
n=5 Participants
|
|
Number of sites of metastastic
2
|
5 patients
n=5 Participants
|
7 patients
n=7 Participants
|
12 patients
n=5 Participants
|
|
Number of sites of metastastic
≥3
|
3 patients
n=5 Participants
|
6 patients
n=7 Participants
|
9 patients
n=5 Participants
|
|
Sites of metastases
Liver
|
3 patients
n=5 Participants
|
12 patients
n=7 Participants
|
15 patients
n=5 Participants
|
|
Sites of metastases
Lung
|
6 patients
n=5 Participants
|
10 patients
n=7 Participants
|
16 patients
n=5 Participants
|
|
Sites of metastases
Bone
|
6 patients
n=5 Participants
|
11 patients
n=7 Participants
|
17 patients
n=5 Participants
|
|
Prior taxane therapy
Paclitaxel
|
4 patients
n=5 Participants
|
9 patients
n=7 Participants
|
13 patients
n=5 Participants
|
|
Prior taxane therapy
Docetaxel
|
5 patients
n=5 Participants
|
10 patients
n=7 Participants
|
15 patients
n=5 Participants
|
|
Prior taxane therapy
Nab-paclitaxel
|
0 patients
n=5 Participants
|
1 patients
n=7 Participants
|
1 patients
n=5 Participants
|
|
Prior taxane therapy
Paclitaxel and docetaxel
|
0 patients
n=5 Participants
|
2 patients
n=7 Participants
|
2 patients
n=5 Participants
|
|
Prior chemotherapy (metastatic setting)
0 Prior chemo therapies
|
5 patients
n=5 Participants
|
0 patients
n=7 Participants
|
5 patients
n=5 Participants
|
|
Prior chemotherapy (metastatic setting)
1 Prior chemo therapies
|
10 patients
n=5 Participants
|
4 patients
n=7 Participants
|
14 patients
n=5 Participants
|
|
Prior chemotherapy (metastatic setting)
2 Prior chemo therapies
|
7 patients
n=5 Participants
|
3 patients
n=7 Participants
|
10 patients
n=5 Participants
|
|
Prior chemotherapy (metastatic setting)
3 Prior chemo therapies
|
0 patients
n=5 Participants
|
2 patients
n=7 Participants
|
2 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsTarget 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.
Outcome measures
| Measure |
Suramin and Paclitaxel
n=9 Participants
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.
|
|---|---|
|
Percentage of Patients That Achieved Target Suramin Concentrations in Plasma
|
88 percent of patients
|
PRIMARY outcome
Timeframe: Up to 8 weeksPer 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.
Outcome measures
| Measure |
Suramin and Paclitaxel
n=22 Participants
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.
|
|---|---|
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Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)
Complete Response (CR)
|
0 patients
|
|
Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)
Partial Response (PR)
|
5 patients
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Objective Response Rate
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.
Outcome measures
| Measure |
Suramin and Paclitaxel
n=22 Participants
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.
|
|---|---|
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Response as Measured by RECIST Criteria
|
23 percentage of patients
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Adverse Events
Suramin and Paclitaxel
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suramin and Paclitaxel
n=31 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
3.2%
1/31 • Number of events 1 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
Other adverse events
| Measure |
Suramin and Paclitaxel
n=31 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
54.8%
17/31 • Number of events 17 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
48.4%
15/31 • Number of events 15 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
45.2%
14/31 • Number of events 14 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
48.4%
15/31 • Number of events 15 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
38.7%
12/31 • Number of events 12 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
96.8%
30/31 • Number of events 30 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.5%
2/31 • Number of events 2 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.7%
3/31 • Number of events 3 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Number of events 1 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Infections and infestations
Infection without neutropenia
|
38.7%
12/31 • Number of events 12 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Investigations
Leukocytes (total WBC)
|
45.2%
14/31 • Number of events 14 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Investigations
Lymphopenia
|
35.5%
11/31 • Number of events 11 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
45.2%
14/31 • Number of events 14 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Gastrointestinal disorders
Nausea
|
54.8%
17/31 • Number of events 17 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Nervous system disorders
Neuropathy - motor
|
16.1%
5/31 • Number of events 5 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Nervous system disorders
Neuropathy-sensory
|
83.9%
26/31 • Number of events 26 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Investigations
Neutropenia
|
25.8%
8/31 • Number of events 8 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Immune system disorders
Non-neutropenic fever
|
22.6%
7/31 • Number of events 7 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
51.6%
16/31 • Number of events 16 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Endocrine disorders
Renal insufficiency
|
16.1%
5/31 • Number of events 5 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Injury, poisoning and procedural complications
Thrombocytopenia
|
6.5%
2/31 • Number of events 2 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Vascular disorders
Thrombosis
|
6.5%
2/31 • Number of events 2 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
|
Gastrointestinal disorders
Vomiting
|
29.0%
9/31 • Number of events 9 • 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.
The NCI Common Toxicity Criteria will be used to grade and quantify toxicity events associated with therapy.
|
Additional Information
Maryam Lustberg, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-0066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60