BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma	Drug: ixabepilone	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Epothilone B Analog (BMS-247550) in Advanced Soft Tissue Sarcomas

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ixabepilone

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Confirmed tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Ninety-five percent confidence intervals will be calculated according to the approach of Duffy and Santner.

Secondary Outcome Measures:

Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
Estimated using the method of Kaplan-Meier.
Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]
Estimated using the method of Kaplan-Meier.
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 ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: Date of registration to date of progression, toxicity, or removal, assessed up to 5 years ] [ Designated as safety issue: No ]
Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]


Enrollment:	26
Study Start Date:	June 2001
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: ixabepilone Given IV Other Names: BMS-247550 epothilone B lactam Ixempra

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022542

Locations


United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Scott Okuno	Mayo Clinic

More Information


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022542 History of Changes
Other Study ID Numbers:	NCI-2012-02397 NCI-2012-02397 MAYO-MC007C CDR0000068829 NCI-3852 MC007C 3852 N01CM17104
Study First Received:	August 10, 2001
Last Updated:	April 14, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Epothilones Epothilone B	Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016