Endometrial CancerPhase 2NCT00006005
Thalidomide in Treating Patients With Gynecologic Sarcomas
A Phase 2 study testing thalidomide in people with Endometrial Cancer and Sarcoma, run by New York University Cancer Institute at 10 sites in United States.
Trial summary
RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer, Sarcoma
- What is being tested?
- thalidomide
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Sep 2000to Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy
- Measurable disease
- Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
- Histologically or cytologically confirmed neoplastic nature if solitary lesion
- No nonmeasurable disease, defined as:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Unconfirmed abdominal masses not followed by imaging techniques
- Cystic lesions
- Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
- Postmenopausal or status post hysterectomy
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin normal
- Transaminases less than 2.5 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
Other:
- No grade 2 or greater peripheral neuropathy
- No medical or social factors that would preclude study, including inability to take oral medication
- No other serious illness requiring immediate therapy
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cancer Center of Albany Medical Center
Albany, New York, 12208
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
North Shore University Hospital
Manhasset, New York, 11030
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, 10019
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
About this study
Official title: Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
Read the detailed description
OBJECTIVES:
- Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
- Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
- Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
- Conditions
- Endometrial Cancer, Sarcoma
- Being tested
- thalidomide
- Keywords
- stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma
- Medical subject headings
- Endometrial Neoplasms, Sarcoma, Sarcoma, Endometrial Stromal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2000
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
Sponsor and investigators
- Lead sponsor
- New York University Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scott Wadler, MD, Study chair, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006005
- Sponsor's protocol ID
- CDR0000068013
- Other IDs
- NYGOG-99-001, NCI-314, NYOG-0102-073
- Status last verified
- Aug 2004
- First submitted
- 5 Jul 2000
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
- ClinicalTrials.gov ID
- NCT00006005
- Acronym / sponsor ID
- CDR0000068013
- Conditions
- Endometrial Cancer, Sarcoma
- Keywords
- stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- New York University Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2000
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Jan 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: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
Detailed description
OBJECTIVES:
- Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
- Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
- Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| thalidomide | 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 21 Jun 2013.
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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.
Scott Wadler, MD study chair
Weill Medical College of Cornell University
10 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 thalidomide in people with Endometrial Cancer and Sarcoma, run by New York University Cancer Institute at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 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 10 sites 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.
Where can I read the original study information?
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 21 Jun 2013.