NCT00025506 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-07-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS) > 6 Months

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outcome · POSTED

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

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Tumor Response

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outcome · POSTED

Overall Survival

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outcome · POSTED

Initial Performance Status

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outcome · POSTED

Initial Histologic Grade

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outcome · NOT POSTED

Serum and Plasma Concentrations of VEGF and bFGF With PFS

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outcome · NOT POSTED

Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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 * 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
healthy Volunteers: false
sex: FEMALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Other: Laboratory Biomarker Analysis
Drug: Thalidomide
label
Treatment (thalidomide)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (thalidomide)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (thalidomide)
description
Given orally
name
Thalidomide
other Names
(+)-Thalidomide
(-)-Thalidomide
.alpha.-Phthalimidoglutarimide
2, 6-Dioxo-3-phthalimidopiperidine
Alpha-Phthalimidoglutarimide
Contergan
Distaval
Kevadon
N-(2,6-Dioxo-3-piperidyl)phthalimide
N-Phthaloylglutamimide
N-Phthalylglutamic Acid Imide
Neurosedyn
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 55
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Serum and Plasma Concentrations of VEGF and bFGF With PFS
time Frame
Up to 5 years
measure
Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF
time Frame
Up to 5 years

primary Outcomes

description
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.
measure
Progression-free Survival (PFS) > 6 Months
time Frame
Every other cycle for 6 months
measure
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)

secondary Outcomes

description
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.
measure
Progression Free Survival
time Frame
Every other cycle until progression or death, up to 5 years.
description
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.
measure
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)
description
The observed length of life from entry into the study to death or the date of last contact.
measure
Overall Survival
time Frame
From study entry to death or last contact, up to 5 years.
description
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.
measure
Initial Performance Status
time Frame
baseline
description
G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
measure
Initial Histologic Grade
time Frame
Baseline

Full study description

brief 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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primary nct id
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https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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nct id
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context exact
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end
11
exact text
NCT00025506
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
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source kind
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice