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

Phase 2
18 Years
Not Enrolling
Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

Thank you

Trial Information

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


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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Scott Okuno

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Sarcoma



Mayo Clinic Rochester, Minnesota  55905