Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054028 |
RATIONALE: 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.
PURPOSE: This phase I/II trial is studying the best dose of suramin when given together with paclitaxel in treating women with stage IIIB or stage IV breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: paclitaxel Drug: suramin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study Of Suramin In Combination With Paclita Xel In Advanced (Stage IIIB or IV) Metastatic Breast Cancer (Phase I and II Portions) |
Estimated Enrollment: | 46 |
Study Start Date: | February 2003 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Phase I
Phase II
OUTLINE: This is a phase I, dose-escalation study of suramin followed by a phase II multicenter study.
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 µM over the duration when paclitaxel levels are therapeutic.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for the phase I study within 9 months. A total of 28 patients will be accrued for the phase II study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced breast cancer
Must have received prior paclitaxel or other taxanes in the adjuvant or metastatic setting
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent steroids or hormones except the following:
Radiotherapy
Surgery
Other
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Charles L. Shapiro, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000269707, OSU-02H0216, NCI-5851, OSU-0216 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054028 |
Health Authority: | United States: Food and Drug Administration |
recurrent breast cancer stage IIIB breast cancer stage IV breast cancer |
Skin Diseases Paclitaxel Suramin |
Breast Neoplasms Breast Diseases Recurrence |
Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Anthelmintics Antimitotic Agents |
Pharmacologic Actions Neoplasms Antiparasitic Agents Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Antinematodal Agents |