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

NCT00054028 | Completed Phase 1 Results

• 7 other identifiers: NCI-2012-014310216OSU-02H0216OSU-0216NCI-5851CDR0000269707U01CA076576
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients That Achieved Target Suramin Concentrations in Plasma

  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.

  Up to 5 years

• Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)

  Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.

  Up to 8 weeks

Secondary Outcomes (1)

• Response as Measured by RECIST Criteria

  Up to 5 years

Study Arms (1)

Treatment (suramin and paclitaxel)

EXPERIMENTAL

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.

Drug: suramin; Drug: paclitaxel; Other: pharmacological study

Interventions

suramin DRUG

Given IV

Also known as: 309 F, Antrypol, Bayer 205, Fourneau 309, Germanin

Treatment (suramin and paclitaxel)

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (suramin and paclitaxel)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (suramin and paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Suramin; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Maryam Lustberg, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Maryam.Lustberg@osumc.edu

614-293-0066

Study Officials

• Charles Shapiro

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: December 1, 2002
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-02

Locations

US (1)