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

Completed · Phase 1/Phase 2

Conditions studied: Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer

In brief

This phase I/II trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer. 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.

Key facts

Study ID

NCT00054028

Run by

National Cancer Institute (NCI)

People needed

31

Starts

2002-12-01

Expected to finish

2008-03-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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