NCT00005807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2000

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2000

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4.1 years

First QC Date

June 2, 2000

Last Update Submit

October 5, 2018

Conditions

Breast CancerOvarian CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerunspecified adult solid tumor, protocol specificovarian stromal cancerstage III ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent ovarian germ cell tumorborderline ovarian surface epithelial-stromal tumorovarian sarcomamale breast cancer

Study Arms (1)

Treated Participants

EXPERIMENTAL

dose escalation treatment

Drug: BMS-247550

Interventions

BMS-247550DRUG

anticancer agent for the treatment of patients with malignant tumors.

Also known as: epothilone derivative
Treated Participants

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • McDaid HM, Mani S, Shen HJ, Muggia F, Sonnichsen D, Horwitz SB. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study. Clin Cancer Res. 2002 Jul;8(7):2035-43.

    PMID: 12114401RESULT

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian EpithelialBreast Neoplasms, Male

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Franco M. Muggia, MD

    NYU Langone Health

    STUDY CHAIR

  • Sridhar Mani, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

US(2)