Clinical trial · Interventional
Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer
A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer
NCT00054028CI-TRIAL-00017145completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (suramin and paclitaxel)
- description
- 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 uM over the duration when paclitaxel levels are therapeutic. PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.
- interventionNames
- Drug: suramin
- Drug: paclitaxel
- Other: pharmacological study
Primary outcomes (2)
- measure
- Percentage of Patients That Achieved Target Suramin Concentrations in Plasma
- timeFrame
- Up to 5 years
- description
- Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.