- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022542
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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:
- Prior chemotherapy for metastatic soft tissue sarcoma (neoadjuvant or adjuvant chemotherapy allowed)
- Prior nitrosoureas or mitomycin C less than or equal to 6 weeks prior to study entry
- Prior other neoadjuvant or adjuvant chemotherapy less than or equal to 4 weeks prior to study entry
- Prior radiotherapy less than or equal to 4 weeks prior to study entry
- Failure to recover from adverse effects of prior therapy regardless of time frame since receiving the therapy
- Concurrent other investigational therapy, unconventional therapies, or food supplements
- Uncontrolled brain metastases; (Note: these patients are excluded because of the poor prognosis and because the propensity for progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events); however, if brain metastases are treated and controlled for > 8 weeks, they would be eligible for this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Epothilone B analog, BMS-247550 or polyoxyethylated castor oil (Cremophor[R] EL)
- Motor or sensory neuropathy >= grade 2 (per NCI CTC version 2.0)
- Known HIV-positive patients receiving combination anti-retroviral therapy; Note: patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy and because of possible pharmacokinetic interactions with Epothilone B analog, BMS-247550; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, treated localized prostate cancer, or other cancer from which the patient has been disease-free for at least 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment (ixabepilone)
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.
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Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 5 years
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Ninety-five percent confidence intervals will be calculated according to the approach of Duffy and Santner.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to disease progression
Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years
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Estimated using the method of Kaplan-Meier.
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Time from registration to documentation of disease progression, assessed up to 5 years
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Overall survival
Time Frame: Time from registration to death due to any cause, assessed up to 5 years
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Estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 5 years
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Quality and duration of responses
Time Frame: 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
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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
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Time to treatment failure
Time Frame: Date of registration to date of progression, toxicity, or removal, assessed up to 5 years
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Date of registration to date of progression, toxicity, or removal, assessed up to 5 years
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Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02397 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- N01CM17104 (U.S. NIH Grant/Contract)
- 3852 (Other Identifier: CTEP)
- MAYO-MC007C
- CDR0000068829
- NCI-3852
- MC007C (Other Identifier: Mayo Clinic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Adult Soft Tissue Sarcoma
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI)WithdrawnRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue SarcomaUnited States, Canada
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National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
-
National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
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Northwestern UniversityAVEO Pharmaceuticals, Inc.CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)National Comprehensive Cancer NetworkCompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)Radiation Therapy Oncology GroupTerminatedRecurrent Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma AJCC v7 | Stage II Adult Soft Tissue Sarcoma AJCC v7 | Stage III Adult Soft Tissue Sarcoma AJCC v7United States
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City of Hope Medical CenterTerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult LiposarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Recurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue SarcomaUnited States, Canada
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Weill Medical College of Cornell UniversityBristol-Myers SquibbCompletedMetastatic Breast CancerUnited States
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R-PharmCompletedSolid MalignanciesUnited States
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