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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Suramin

Criteria

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