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A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer


PRIMARY OBJECTIVES:

I. Determine the dose of suramin in combination with paclitaxel (TXT) that results in
suramin plasma concentrations approaching 10-50 uM over the duration, when TXT in the plasma
is at therapeutically significant levels, in women with stage IIIB or IV breast cancer.
(Phase I) II. Determine the objective response rate in patients treated with this regimen.
(Phase II)

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) II.
Determine the time to tumor progression in patients treated with this regimen. (Phase II)
III. Determine the 1-year survival of patients treated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of suramin followed by a phase II
multicenter study.

PHASE I: Patients receive low-dose suramin intravenously (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.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for the phase I study within 9
months. A total of 28 patients will be accrued for the phase II study within 18-24 months.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed stage IIIB or IV
metastatic breast cancer (MBC)

- Prior chemotherapy:

- Phase I: patients must have received prior paclitaxel or other taxanes in either
the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery
must be completed at least 21 days before study entry; prior treatment with
anthracyclines is not required

- Phase II: up to two prior chemotherapy regimens for stage IIIB or IV MBC;
patients must have received prior paclitaxel or other taxanes in either the
adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be
completed at least 21 days before study entry; prior treatment with
anthracyclines is not required

- Measurable disease (phase II)

- No known brain metastases

- Hormone receptor status:

- Not specified

- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2

- White blood cell (WBC) at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

- Bilirubin no greater than 1.5 mg/dL

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5
times upper limit of normal

- Creatinine no greater than 1.5 mg/dL

- Left ventricular ejection fraction (LVEF) at least lower limit of normal

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergic reactions attributable to compounds of similar chemical or
biological composition to Cremophor

- No concurrent uncontrolled illness that would preclude study compliance

- No ongoing or active infection

- No uncontrolled diabetes mellitus

- No psychiatric illness or social situations that would preclude study compliance

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- No more than 2 prior chemotherapy regimens for this malignancy (phase II)

- No concurrent steroids or hormones except the following:

- Steroids to prevent hypersensitivity reactions prior to paclitaxel
administration

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- At least 3 weeks since prior radiotherapy and recovered

- At least 3 weeks since prior surgery and recovered

- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients

- No other concurrent investigational agents

- Concurrent bisphosphonates (i.e., pamidronate or zoledronate) are allowed for the
treatment of hypercalcemia or palliation of skeletal metastases

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Target suramin dose (Phase I)

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Charles Shapiro

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01431

NCT ID:

NCT00054028

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210