Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer - Full Text View

Sponsor:	Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054028

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the best dose of suramin when given together with paclitaxel in treating women with stage IIIB or stage IV breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: paclitaxel Drug: suramin	Phase I Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Suramin Hexasodium Suramin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Target suramin dose (Phase I) [ Designated as safety issue: No ]
Objective response rate (complete response and partial response) as measured by RECIST criteria (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response as measured by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	February 2003
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Phase I

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.
Determine the pharmacokinetics of low-dose suramin in these patients.

Phase II

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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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/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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054028

Locations

United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240

Sponsors and Collaborators

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Shapiro, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00054028 History of Changes
Other Study ID Numbers:	CDR0000269707, OSU-02H0216, NCI-5851, OSU-0216
Study First Received:	February 5, 2003
Last Updated:	February 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage IIIB breast cancer
stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Suramin
Paclitaxel
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012