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Recurrent Adult Soft Tissue SarcomaPhase 2NCT00022542

BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase 2 study testing ixabepilone in people with Recurrent Adult Soft Tissue Sarcoma and Stage III Adult Soft Tissue Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Jun 2001to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
ixabepilone
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

Study groups in NCT00022542
Study groupRoleWhat they receive
Treatment (ixabepilone)ExperimentalPatients 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.
Receives: Drug: ixabepilone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Overall survival

    Estimated using the method of Kaplan-Meier.

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

  2. Time to disease progression

    Estimated using the method of Kaplan-Meier.

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

  3. Quality and duration of responses

    Measured: 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

  4. Time to treatment failure

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

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

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2004 (estimated)
  2. Study startJun 2001
  3. Primary completionJun 2006
  4. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022542
Sponsor's protocol ID
NCI-2012-02397
Other IDs
NCI-2012-02397, MAYO-MC007C, CDR0000068829, NCI-3852, MC007C, 3852, N01CM17104
Status last verified
Dec 2012
First submitted
10 Aug 2001
Last updated
15 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Recurrent Adult Soft Tissue Sarcoma and Stage III Adult Soft Tissue Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00022542.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.

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