BMS-247550 in Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or unresectable solid tumors.
|Breast Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: ixabepilone||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Scientific Exploratory Study of Epothilone B Analog (BMS-247550; NSC #710428) in Patients With Solid Tumors and Gynecological Malignancies|
|Study Start Date:||July 2000|
- Determine the maximum tolerated dose, recommended phase II dose, and associated toxic effects of BMS-247550 in patients with advanced solid tumors.
- Determine the pharmacokinetic and pharmacodynamic relationship of this treatment regimen in these patients.
- Assess the extent of microtubule bundle and mitotic aster formation and cell cycle kinetics in peripheral blood mononuclear cells in these patients treated with this regimen.
- Determine any evidence of antitumor activity of this treatment regimen in these patients.
- Evaluate the relationship between tumor response and the occurrence of mutation in the class 1 isotype of B-tubulin and B-tubulin isotype distribution in patients with advanced or recurrent solid tumors, ovarian cancer, or breast cancer treated with this regimen.
- Investigate MDR1, MRP, and cMOAT mRNA and protein expression as prognosticators of tumor response in these patients treated with this regimen.
- Determine the relationship between stathmin expression and phosphorylation status as a function of response in these patients treated with this regimen.
- Correlate the expression of proapoptotic (p53, bax, bad, and bid) and antiapoptotic (survivin, inhibitors of apoptotic proteins, bcl-2, and bcl-x) proteins in tumor samples and/or ascites with response and clinical outcome in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
- Part I: Patients with advanced solid tumors receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Part II: Patients with ovarian, breast, or other cancer receive BMS-247550 as in the part I portion of the study at the MTD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 months.
PROJECTED ACCRUAL: Approximately 42-66 patients will be accrued for this study within 12-16 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005807
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|