Recurrent Uterine Corpus SarcomaPhase 2NCT00025220
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
A Phase 2 study testing Thalidomide and Laboratory Biomarker Analysis in people with Recurrent Uterine Corpus Sarcoma and Uterine Corpus Leiomyosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma
- What is being tested?
- Thalidomide and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments
- Recurrent or persistent disease
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- Tumors within a previously irradiated field are considered non-target lesions
- No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
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- Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
- Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population
- No documented brain metastases since diagnosis of cancer
- Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI
- Performance status - GOG 0-2 if received 1 prior therapy regimen
- Performance status - GOG 0-1 if received 2 prior therapy regimens
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance greater than 60 mL/min
- No documented seizure disorders since diagnosis of cancer
- Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months)while on an appropriately monitored treatment regimen
- No active infection requiring antibiotics
- No greater than grade 1 sensory or motor neuropathy
- No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant
- Negative pregnancy test
- Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
- No prior thalidomide
- At least 3 weeks since prior immunologic agents for uterine LMS
- At least 3 weeks since other prior chemotherapy for uterine LMS and recovered
- No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine LMS
- No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS
- At least 1 week since prior hormonal therapy for uterine LMS
- Concurrent hormone replacement therapy allowed
- At least 3 weeks since prior radiotherapy for uterine LMS and recovered
- No prior radiotherapy to more than 25% of bone marrow
- Recovered from recent prior surgery
- No prior anticancer therapy that would preclude study therapy
- At least 3 weeks since other prior therapy for uterine LMS
- No concurrent bisphosphonates (e.g., zoledronate)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
- Determine the effect of this drug on initial performance status in these patients.
VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide 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 2 years, every 6 months for 3 years, and then annually thereafter.
- Being tested
- Thalidomide, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called THAL
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (thalidomide) | Experimental | Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Thalidomide; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 6 months
Frequency and severity of adverse effects as assessed by CTC
Measured: Up to 7 years
Secondary outcomes (3)
Duration of progression-free survival
Measured: Up to 7 years
Duration of overall survival
Measured: Up to 7 years
Frequency of clinical response (partial and complete response)
Measured: Up to 7 years
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 2001
- Primary completionApr 2003
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Uterine Corpus SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- D. McMeekin, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025220
- Sponsor's protocol ID
- NCI-2012-02415
- Other IDs
- NCI-2012-02415, CDR0000068939, GOG-0231-B, GOG-0231B, U10CA027469
- Status last verified
- Jul 2019
- First submitted
- 11 Oct 2001
- Last updated
- 23 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
- ClinicalTrials.gov ID
- NCT00025220
- Acronym / sponsor ID
- NCI-2012-02415
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Gynecologic Oncology Group
- Study start
- Sep 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Jul 2008 (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.
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
Detailed description
PRIMARY OBJECTIVES:
- Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
- Determine the effect of this drug on initial performance status in these patients.
VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide 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 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (thalidomide) | Experimental | Drug: Thalidomide, Other: Laboratory Biomarker AnalysisPatients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (40 listed)
- Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments
- At least 1 unidimensionally measurable target lesion
- No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
- Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
- Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ThalidomideAlso: THALGiven PO | Drug | Treatment (thalidomide) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (thalidomide) |
Primary outcome
Progression-free survival
Time frame: 6 months
Frequency and severity of adverse effects as assessed by CTC
Time frame: Up to 7 years
3 secondary outcomes
Duration of progression-free survival
Time frame: Up to 7 years
Duration of overall survival
Time frame: Up to 7 years
Frequency of clinical response (partial and complete response)
Time frame: Up to 7 years
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 23 Jul 2019.
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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.
D. McMeekin principal investigator
Gynecologic Oncology Group
1 site 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 and Laboratory Biomarker Analysis in people with Recurrent Uterine Corpus Sarcoma and Uterine Corpus Leiomyosarcoma, 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 40 inclusion and 0 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 23 Jul 2019. 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 survival (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 23 Jul 2019.