Endometrial CancerPhase 2NCT00053794
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
A Phase 2 study testing perifosine in people with Endometrial Cancer and Sarcoma, run by NCIC Clinical Trials Group at 6 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Endometrial Cancer, Sarcoma
- What is being tested?
- perifosine
- How many people
- 17 participants
- Where
- 6 sitesCanada
- Study dates
- 9 Jun 2003to 22 Sep 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic or locally advanced soft tissue sarcoma that is incurable by standard therapies, including any of the following types:
- Uterine sarcomas
- Mixed mesodermal
- Leiomyosarcoma
- Endometrial stromal sarcoma
- Alveolar soft part sarcoma
- Angiosarcoma/lymphangiosarcoma
- Fibrosarcoma
- Hemangiopericytoma
- Leiomyosarcoma
- Liposarcoma
- Malignant fibrous histiocytoma
- Neurogenic sarcoma
- Pleomorphic rhabdomyosarcoma
- Synovial sarcoma
- Unclassifiable sarcoma
- Undifferentiated sarcoma
- Excluded diseases include the following:
- Bone sarcomas (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma)
- Embryonal rhabdomyosarcoma
- Carcinosarcoma
- Kaposi's sarcoma
- Malignant mesothelioma
- Neuroblastoma
- Gastrointestinal stromal tumor
- At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as:
- At least 20 mm by x-ray or physical exam
- At least 10 mm by spiral CT scan
- At least 20 mm by non-spiral CT scan NOTE: Bone lesions are not considered measurable
NOTE: Patients whose sole site of disease is within a previously irradiated area are allowed if there is evidence of progression or new lesions in the irradiated field
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than ULN
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- No active or ongoing infection
- No psychiatric illness or social situation that would limit compliance with study requirements
- No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy for metastatic or locally advanced disease
- At least 6 months since prior adjuvant chemotherapy
- No other concurrent cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy)
- No concurrent radiotherapy to the sole site of measurable disease or for progressively symptomatic disease
Surgery
- At least 4 weeks since prior major surgery
Other
- No other concurrent anticancer therapy or investigational agents
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of perifosine, in terms of response rate and duration of response, in patients with untreated metastatic or locally advanced soft tissue sarcoma.
- Determine the toxicity of this drug in these patients.
- Determine the early progression rate in patients treated with this drug.
OUTLINE: This is a non-randomized, non-blinded, multicenter study.
Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course. For all subsequent courses, patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 1 month. Patients with stable or responsive disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
- Conditions
- Endometrial Cancer, Sarcoma
- Being tested
- perifosine
- Keywords
- adult alveolar soft-part sarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult synovial sarcoma, endometrial stromal sarcoma, uterine leiomyosarcoma, adult malignant hemangiopericytoma, stage III adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent adult soft tissue sarcoma, recurrent uterine sarcoma, adult malignant fibrous histiocytoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, stage IV adult soft tissue sarcoma
- Medical subject headings
- Endometrial Neoplasms, Sarcoma, Sarcoma, Alveolar Soft Part, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study start9 Jun 2003
- Primary completion18 Sep 2004
- Study completion22 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth A. Eisenhauer, MD, Study chair, Cancer Centre of Southeastern Ontario at Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053794
- Sponsor's protocol ID
- I155
- Other IDs
- CAN-NCIC-IND155, CDR0000269476
- Status last verified
- Apr 2020
- First submitted
- 5 Feb 2003
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knowling M, Blackstein M, Tozer R, Bramwell V, Dancey J, Dore N, Matthews S, Eisenhauer E. A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2006 Sep;24(5):435-9. doi: 10.1007/s10637-006-6406-7.
PubMed 16528479
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00053794
- Acronym / sponsor ID
- I155
- Conditions
- Endometrial Cancer, Sarcoma
- Keywords
- adult alveolar soft-part sarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult synovial sarcoma, endometrial stromal sarcoma, uterine leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jun 2003 (actual)
- Primary completion
- 18 Sep 2004 (actual)
- Study completion
- 22 Sep 2008 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma.
Detailed description
OBJECTIVES:
- Determine the efficacy of perifosine, in terms of response rate and duration of response, in patients with untreated metastatic or locally advanced soft tissue sarcoma.
- Determine the toxicity of this drug in these patients.
- Determine the early progression rate in patients treated with this drug.
OUTLINE: This is a non-randomized, non-blinded, multicenter study.
Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course. For all subsequent courses, patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 1 month. Patients with stable or responsive disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perifosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publication: PubMed 16528479Knowling M, Blackstein M, Tozer R, Bramwell V, Dancey J, Dore N, Matthews S, Eisenhauer E. A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2006 Sep;24(5):435-9. doi: 10.1007/s10637-006-6406-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Eisenhauer, MD study chair
Cancer Centre of Southeastern Ontario at Kingston General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perifosine in people with Endometrial Cancer and Sarcoma, run by NCIC Clinical Trials Group at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00053794, which also lists 1 linked publication.
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 Aug 2023.