Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer
- Conditions
- Breast CancerOvarian CancerUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00005807
- Lead Sponsor
- Albert Einstein College of Medicine
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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 Multi-Drug Resistance Gene (MDR1), Multidrug Resistance-associated Protein (MRP) Gene, and canalicular multispecific organic anion transporter 1(cMOAT) messenger ribonucleic acid (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Histologically or cytologically confirmed metastatic or unresectable solid malignancy for which no standard or curative therapies exist or are no longer effective
- Metastatic, recurrent, or locally advanced breast, ovarian, or other cancer
- Hemoglobin at least 9.0 g/dL
- WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin normal
- AST/ALT no greater than 3 times upper limit of normal
- Gilbert's syndrome allowed
- Creatinine no greater than 2 mg/dL
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
- grade 2 or greater clinical neuropathy
- prior allergy or hypersensitivity reaction (grade 2 or greater) to prior paclitaxel or other therapy containing Cremophor EL
- allergy or intolerance to steroids, diphenhydramine, cimetidine, or ranitidine
- uncontrolled concurrent illness
- active infection
- pregnant or nursing
- other concurrent anticancer therapies or commercial agents
- other concurrent investigational agents
- other concurrent highly active antiretroviral therapy for HIV-positive patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated Participants BMS-247550 dose escalation treatment
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States