NCT00022542

Brief Summary

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

June 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

February 27, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 15, 2015

Status Verified

December 1, 2012

Enrollment Period

5 years

First QC Date

August 10, 2001

Last Update Submit

April 14, 2015

Conditions

Recurrent Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Confirmed tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST)

    Ninety-five percent confidence intervals will be calculated according to the approach of Duffy and Santner.

    Up to 5 years

Secondary Outcomes (5)

  • Overall survival

    Time from registration to death due to any cause, assessed up to 5 years

  • Time to disease progression

    Time from registration to documentation of disease progression, assessed up to 5 years

  • Quality and duration of responses

    Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years

  • Time to treatment failure

    Date of registration to date of progression, toxicity, or removal, assessed up to 5 years

  • Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Up to 5 years

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive 2 additional courses.

Drug: ixabepilone

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra
Treatment (ixabepilone)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed soft tissue sarcoma with evidence of metastatic or unresectable disease
  • Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2.0 cm with conventional techniques
  • Life expectancy of \>= 12 weeks
  • ECOG performance status 0, 1, or 2
  • Absolute neutrophil count \>= 1,500/uL
  • Platelets \>= 100,000/uL
  • Total bilirubin =\< 1.5 x institutional ULN
  • AST(SGOT) =\< 2.5 x institutional ULN
  • Creatinine =\< 1.5 x institutional ULN or creatinine clearance \>= 60 mL/min for patients with creatinine levels \> 1.5 x institutional ULN
  • Capable of understating the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

You may not qualify if:

  • Any of the following as the effects of Epothilone B analog, BMS-247550, on the developing fetus or nursing child, at the recommended therapeutic dose are unknown:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Only non-measurable disease, including lesions not clearly measurable in one dimension, small lesions (longest diameter \< 2.0 cm), and truly non-measurable lesions, which include the following as per RECIST criteria:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericaridial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Only a single measurable lesion and that lesion has been irradiated unless there has been a documented \> 25% increase in size since completion of radiation
  • Any of the following:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Scott Okuno

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

February 27, 2004

Study Start

June 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

April 15, 2015

Record last verified: 2012-12

Locations

US(1)