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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 December 2012
• Main ID: NCT00054028
• Date of registration: 05/02/2003
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer
• Scientific title: A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer
• Date of first enrolment: February 2003
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00054028
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Charles Shapiro
• Affiliation: Ohio State University Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Recurrent Breast Cancer

Stage IIIB Breast Cancer

Stage IV Breast Cancer

Intervention(s)

Drug: paclitaxel

Drug: suramin

Other: pharmacological study

Primary Outcome(s)

Objective response rate (complete response and partial response) as measured by RECIST criteria (Phase II) [Time Frame: Up to 5 years]

Target suramin dose (Phase I) [Time Frame: Up to 5 years]

Secondary Outcome(s)

Response as measured by RECIST criteria [Time Frame: Up to 5 years]

Secondary ID(s)

0216

CDR0000269707

NCI-2012-01431

U01CA076576

Source(s) of Monetary Support

Please refer to primary and secondary sponsors