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Recurrent Adult Soft Tissue SarcomaPhase 2NCT00064324

Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase 2 study testing perifosine, laboratory biomarker analysis and pharmacological study 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine 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?
perifosine, laboratory biomarker analysis and pharmacological study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
Jun 2003to Nov 2005
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 confirmed advanced soft tissue sarcoma
  • Measurable disease; measurable disease lesions that are being monitored for response and have been previously irradiated must have progressed > 25% since completion of radiation therapy
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • PLT >= 100,000/uL
  • Total bilirubin =< upper normal limit (UNL)
  • AST =< 2.5 x UNL
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  • Creatinine =< UNL or calculated creatinine clearance >= 60 mL/min (i.e. using the Cockcroft-Gault or Jeliffe methods)
  • Life expectancy >= 12 weeks
  • ECOG performance status (PS) 0 or 1
  • Capable of understanding 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 this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Breastfeeding women
  • Men or 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.)
  • NOTE: Pregnant women are excluded from this study because perifosine is an alkylphospholipid with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with perifosine, breastfeeding should be discontinued if the mother is treated with perifosine
  • Any of the following:
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  • >= 3 prior cytotoxic chemotherapy regimens for metastatic sarcoma
  • Chemotherapy =< 4 weeks prior to study entry
  • Nitrosoureas or mitomycin C =< 6 weeks prior to study entry
  • Radiotherapy =< 4 weeks prior to study entry
  • Immunotherapy =< 4 weeks prior to study entry
  • Biologic therapy =< 4 weeks prior to study entry
  • Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
  • Uncontrolled brain metastases; NOTE: these patients are excluded because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; however, if brain metastasis are treated and controlled for > 8 weeks, the patient would be eligible for this study
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia despite appropriate therapy, or psychiatric illness/social situations that would limit compliance with study requirements
  • HIV-positive patients receiving combination anti-retroviral therapy; NOTE: these patients are excluded from the study because of possible pharmacokinetic interactions with perifosine; appropriate studies may be undertaken in patients receiving combination anti-retroviral therapy when indicated
  • Prior malignancy, except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated noninvasive carcinoma
  • Other invasive cancer from which the patient has been disease-free for 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 Perifosine in Soft Tissue Sarcoma

Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma.

SECONDARY OBJECTIVES:

  1. To evaluate survival and time to progression. II. To evaluate objective tumor response status and duration. III. To evaluate adverse event rates. IV. To evaluate patterns of treatment failure. V. To evaluate pharmacokinetics.

OUTLINE: This is a multicenter study.

Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.

Being tested
perifosine, laboratory biomarker analysis, pharmacological study
Medical subject headings
Sarcoma

What participants receive

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

  • perifosineDrug

    Also called D21266, octadecylphosphopiperidine

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00064324
Study groupRoleWhat they receive
Arm IExperimentalPatients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: perifosine; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Progression-free rate

    Measured: 6 months

Secondary outcomes (5)

  1. Survival time

    Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.

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

  2. Time to disease progression

    Estimated using the method of Kaplan-Meier (Kaplan and Meier 1958) and Cox Proportional Hazards (Cox D. 1972) modeling.

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

  3. Duration of response

    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: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years

  5. Average change over time for PK variable(s)

    Estimated and tested via appropriate methods (i.e. t-test or Wilcoxon tests).

    Measured: Days 1 and 15 of course 1 and day 1 of courses 2-6

Timeline

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

  1. First posted9 Jul 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionNov 2005

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064324
Sponsor's protocol ID
NCI-2012-02798
Other IDs
MC0276, 5972, N01CM17104
Status last verified
Jun 2013
First submitted
8 Jul 2003
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing perifosine, laboratory biomarker analysis and pharmacological study 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 22 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: finished, as of the sponsor's last update on 4 Jun 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free rate (time frame: 6 months). 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 NCT00064324.

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 4 Jun 2013.

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