Recurrent Uterine Corpus SarcomaPhase 2NCT00025506

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

A Phase 2 study testing Laboratory Biomarker Analysis and Thalidomide in people with Recurrent Uterine Corpus Sarcoma and Uterine Carcinosarcoma, 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

This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. 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 Carcinosarcoma
What is being tested?: Laboratory Biomarker Analysis and Thalidomide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: Sep 2001to Jan 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 uterine sarcoma
Carcinosarcoma (malignant mixed müllerian tumor)
Homologous or heterologous type
Recurrent or persistent with documented disease progression after prior local therapy
At least 1 unidimensionally measurable target lesion
At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI

Show all 45Show fewer

At least 10 mm by spiral CT scan
Tumors within a previously irradiated field are considered non-target lesions
Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
No documented brain metastases since diagnosis of cancer
Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population
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
Not pregnant
Negative pregnancy test
Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
No 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 invasive malignancy within the past 5 years except nonmelanoma skin cancer
At least 3 weeks since prior immunologic agents for uterine sarcoma
No prior thalidomide
See Disease Characteristics
At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma
No concurrent bisphosphonates (e.g., zoledronate)
At least 1 week since prior hormonal therapy for uterine sarcoma
Concurrent hormone replacement therapy allowed
See Disease Characteristics
At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
No prior radiotherapy to more than 25% of marrow-bearing areas
See Disease Characteristics
Recovered from prior surgery
At least 3 weeks since any other prior therapy for uterine sarcoma
No prior anticancer therapy that would preclude study

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Read the detailed description

OBJECTIVES: Primary I. 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 carcinosarcoma.

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the partial and complete response rates in patients treated with this drug.

II. Determine the duration of PFS and overall survival of patients treated with this drug.

III. Determine the effect of this drug on initial performance status and histological grade in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., 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 28 days 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 19-51 patients will be accrued for this study within 3 years.

Conditions: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
Being tested: Laboratory Biomarker Analysis, Thalidomide

What participants receive

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

Laboratory Biomarker AnalysisOther
Correlative studies
ThalidomideDrug
Also called (+)-Thalidomide, (-)-Thalidomide, .alpha.-Phthalimidoglutarimide, 2, 6-Dioxo-3-phthalimidopiperidine
Given orally

Study groups in NCT00025506
Study group	Role	What they receive
Treatment (thalidomide)	Experimental	Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Thalidomide

What is being measured

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

Progression-free Survival (PFS) > 6 Months
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Measured: Every other cycle for 6 months
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
Measured: Each cycle during treatment and 30 days after the last treatment (average 4 months)

Secondary outcomes (5)

Progression Free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Measured: Every other cycle until progression or death, up to 5 years.
Tumor Response
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Measured: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Measured: From study entry to death or last contact, up to 5 years.
Initial Performance Status
Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.
Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Measured: baseline
Initial Histologic Grade
G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Measured: Baseline

Timeline

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

Sep 2001Jan 2013

First posted27 Jan 2003 (estimated)
Study startSep 2001
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00025506
Sponsor's protocol ID: NCI-2012-02421
Other IDs: NCI-2012-02421, CDR0000068967, GOG-0230B, GOG-0230B, U10CA027469
Status last verified: Jul 2019
First submitted: 11 Oct 2001
Last updated: 24 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 24 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 Carcinosarcoma of the Uterus
ClinicalTrials.gov ID: NCT00025506
Acronym / sponsor ID: NCI-2012-02421
Conditions: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Collaborators: Gynecologic Oncology Group
Study start: Sep 2001
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 27 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the partial and complete response rates in patients treated with this drug.

II. Determine the duration of PFS and overall survival of patients treated with this drug.

III. Determine the effect of this drug on initial performance status and histological grade in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., 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 28 days 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 19-51 patients will be accrued for this study within 3 years.

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	Other: Laboratory Biomarker Analysis, Drug: ThalidomidePatients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days 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 (45 listed)

Histologically confirmed uterine sarcoma
Recurrent or persistent with documented disease progression after prior local therapy
At least 1 unidimensionally measurable target lesion
Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
No documented brain metastases since diagnosis of cancer

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
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (thalidomide)
ThalidomideAlso: (+)-Thalidomide, (-)-Thalidomide, .alpha.-Phthalimidoglutarimide, 2, 6-Dioxo-3-phthalimidopiperidineGiven orally	Drug	Treatment (thalidomide)

Primary outcome

Progression-free Survival (PFS) > 6 Months
Time frame: Every other cycle for 6 months
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
Time frame: Each cycle during treatment and 30 days after the last treatment (average 4 months)

5 secondary outcomes

Progression Free Survival
Time frame: Every other cycle until progression or death, up to 5 years.
Tumor Response
Time frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)
Overall Survival
Time frame: From study entry to death or last contact, up to 5 years.
Initial Performance Status
Time frame: baseline
Initial Histologic Grade
Time frame: Baseline

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Thalidomide	55	45

Primary outcome: Progression-free Survival (PFS) > 6 Months

Time frame: Every other cycle for 6 months. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Thalidomide n = 45
Value	17.8 (9 to 30)

Population analysed: Eligible and treated patients.

Primary outcome: Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0

Time frame: Each cycle during treatment and 30 days after the last treatment (average 4 months). Count of participants. Unit: Participants

Measure	Grade 0 n = 45	Grade 1 n = 45	Grade 2 n = 45	Grade 3 n = 45	Grade 4 n = 45
Nausea	31	4	6	4	0
Vomiting	36	4	4	1	0
Constipation	27	6	9	3	0
Anorexia	42	2	1	0	0
Fatigue	22	5	15	3	0
Neutropenia	41	1	3	0	0
Thrombocytopenia	44	1	0	0	0
Anemia	22	9	9	4	1

Population analysed: Eligible and evaluable patients

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Thalidomide	15 of 45 (33.3%)	45 of 45 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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?

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 45 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 24 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?

Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS) > 6 Months (time frame: Every other cycle for 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?

On the ClinicalTrials.gov record for NCT00025506.

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 24 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.