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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005807
First received: June 2, 2000
Last updated: July 23, 2008
Last verified: September 2003
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: ixabepilone
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Ixabepilone
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):
Study Start Date: July 2000
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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Part I:

    • Histologically or cytologically confirmed metastatic or unresectable solid malignancy for which no standard or curative therapies exist or are no longer effective

  • Part II:

    • Metastatic, recurrent, or locally advanced breast, ovarian, or other cancer

      • At least 1 site amenable to biopsy
    • No known brain metastases

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin normal
  • AST/ALT no greater than 3 times upper limit of normal
  • Gilbert's syndrome allowed

Renal:

  • Creatinine no greater than 2 mg/dL

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • No grade 2 or greater clinical neuropathy
  • No prior allergy or hypersensitivity reaction (grade 2 or greater) to prior paclitaxel or other therapy containing Cremophor EL
  • No allergy or intolerance to steroids, diphenhydramine, cimetidine, or ranitidine
  • No other uncontrolled concurrent illness
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No prior radiotherapy to more than 35% of bone marrow
  • Prior whole pelvic radiotherapy allowed

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent anticancer therapies or commercial agents
  • No other concurrent investigational agents
  • No concurrent highly active antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005807

Locations
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 of Yeshiva University
National Cancer Institute (NCI)
Investigators
Study Chair: Franco M. Muggia, MD New York University School of Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005807     History of Changes
Other Study ID Numbers: CDR0000067800  AECM-9911378  NCI-98  NYU-0006 
Study First Received: June 2, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 29, 2016