Loading clinical trials...

BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase II Study of Epothilone B Analog (BMS-247550) in Advanced Soft Tissue Sarcomas

NCT00022542•National Cancer Institute (NCI)

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.

Detailed Description

OBJECTIVES: I. Determine the confirmed response rate of patients with advanced soft tissue sarcoma treated with BMS-247550. II. Determine the overall survival and progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. 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. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study within 8 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+17 more criteria

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

June 1, 2001

Primary Completion Date

June 1, 2006

Completion Date

June 1, 2006

Last Updated

April 15, 2015

Enrollment

ACTUAL participants

Conditions

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

Interventions

ixabepilone

DRUG

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

NCT02701153

Recurrent Adult Soft Tissue Sarcoma

View study

ACTIVE_NOT_RECRUITINGPHASE1

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

NCT01552434

Advanced Malignant NeoplasmCastleman Disease+37 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall