Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	OSU-02H0216 NCI-5851, OSU-0216, NCT00054028, 5851

Objectives

Phase I

1. Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 µM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer.
2. Determine the pharmacokinetics of low-dose suramin in these patients.

Phase II

1. Determine the objective response rate in patients treated with this regimen.
2. Determine the time to tumor progression in patients treated with this regimen.
3. Determine the 1-year survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed advanced breast cancer
  • Stage IIIB or IV



• Measurable disease (phase II)



• Must have received prior paclitaxel or other taxanes in the adjuvant or metastatic setting
  • Prior treatment with anthracyclines is not required



• No known brain metastases



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• 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)

Endocrine therapy

• 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)

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• At least 3 weeks since prior surgery and recovered

Other

• No concurrent combination antiretroviral therapy for 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

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• LVEF at least lower limit of normal
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

Expected Enrollment

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.

Outcomes

Target suramin dose (Phase I)
Objective response rate (complete response and partial response) as measured by RECIST criteria (Phase II)

Response as measured by RECIST criteria

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 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 µM over the duration when paclitaxel levels are therapeutic.




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

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu

Registry Information
Official Title		A Phase I/II Study Of Suramin In Combination With Paclita xel In Advanced (Stage IIIB or IV) Metastatic Breast Cancer (Phase I and II Portions)
Trial Start Date		2003-02-05
Trial Completion Date		2008-03-13
Registered in ClinicalTrials.gov		NCT00054028
Date Submitted to PDQ		2002-12-13
Information Last Verified		2007-10-04
NCI Grant/Contract Number		CA76576, CA16058

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