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Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer (BMS-247550)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005807
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: BMS-247550 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Scientific Exploratory Study of Epothilone B Analog in Patients With Solid Tumors and Gynecological Malignancies
Actual Study Start Date : July 2000
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004


Arm Intervention/treatment
Experimental: Treated Participants
dose escalation treatment
Drug: BMS-247550
anticancer agent for the treatment of patients with malignant tumors.
Other Name: epothilone derivative





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005807


Locations
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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
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Study Chair: Franco M. Muggia, MD NYU Langone Health
Principal Investigator: Sridhar Mani, MD Albert Einstein College of Medicine
Publications of Results:
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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00005807    
Other Study ID Numbers: CDR0000067800
AECM-9911378
NCI-98
NYU-0006
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Albert Einstein College of Medicine:
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
unspecified adult solid tumor, protocol specific
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
borderline ovarian surface epithelial-stromal tumor
ovarian sarcoma
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents