Trial · NCT00025506

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

NCT00025506, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus. Trials, record NCT00025506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00025506

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
NCT number: NCT00025506
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
Interventions: Laboratory Biomarker Analysis, Thalidomide
First posted: 2003-01-27
Last updated: 2019-07-24
Results first posted: 2015-05-27

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) > 6 Months	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.
Primary	Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Each cycle during treatment and 30 days after the last treatment (average 4 months)
Secondary	Progression Free Survival	Every other cycle until progression or death, up to 5 years.	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.
Secondary	Tumor Response	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)	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.
Secondary	Overall Survival	From study entry to death or last contact, up to 5 years.	The observed length of life from entry into the study to death or the date of last contact.
Secondary	Initial Performance Status	baseline	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.
Secondary	Initial Histologic Grade	Baseline	G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Other	Serum and Plasma Concentrations of VEGF and bFGF With PFS	Up to 5 years
Other	Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF	Up to 5 years

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS) > 6 Months	Every other cycle for 6 months	Eligible and treated patients.	percentage of participants	NUMBER
PRIMARY	Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Each cycle during treatment and 30 days after the last treatment (average 4 months)	Eligible and evaluable patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	Every other cycle until progression or death, up to 5 years.	Eligible and treated patients	months	MEDIAN
SECONDARY	Tumor Response	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)	Eligible and treated patients.	percentage of participants	NUMBER
SECONDARY	Overall Survival	From study entry to death or last contact, up to 5 years.	Eligible and treated patients.	months	MEDIAN
SECONDARY	Initial Performance Status	baseline	Eligible and evaluable patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Initial Histologic Grade	Baseline	Eligible and evaluable patients	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Serum and Plasma Concentrations of VEGF and bFGF With PFS	Up to 5 years
OTHER_PRE_SPECIFIED	Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF	Up to 5 years

Source ClinicalTrials.gov

Results by group79

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS) > 6 Months	Thalidomide		17.8	90% Confidence Interval 9 to 30	percentage of participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 0	Nausea	31		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 1	Nausea	4		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 2	Nausea	6		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 3	Nausea	4		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 4	Nausea	0		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 0	Vomiting	36		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 1	Vomiting	4		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 2	Vomiting	4		Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0	Grade 3	Vomiting	1		Participants

1 to 10 of 79Source ClinicalTrials.gov

See all 79 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Thalidomide	55
Overall Study	COMPLETED	Thalidomide	45
Overall Study	NOT COMPLETED	Thalidomide	10

Source ClinicalTrials.gov

Adverse events99

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Inner Ear/Hearing	Ear and labyrinth disorders	Thalidomide	1	45
other	Neutropenia	Blood and lymphatic system disorders	Thalidomide	4	45
other	Thrombocytopenia	Blood and lymphatic system disorders	Thalidomide	2	45
other	Lymphopenia	Blood and lymphatic system disorders	Thalidomide	1	45
other	Leukopenia	Blood and lymphatic system disorders	Thalidomide	6	45
other	Transfusion Prbc's	Blood and lymphatic system disorders	Thalidomide	7	45
other	Anemia	Blood and lymphatic system disorders	Thalidomide	29	45
other	Transfusion Platelets	Blood and lymphatic system disorders	Thalidomide	1	45
other	Arrhythmia Nodal/Junctional Dysrhythmia	Cardiac disorders	Thalidomide	1	45
other	Edema	Cardiac disorders	Thalidomide	12	45

1 to 10 of 99Source ClinicalTrials.gov

See all 99 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Thalidomide
Total, other adverse events	Thalidomide	45	45
Total, serious adverse events	Thalidomide	15	45

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00025506

GET https://conductscience.org/api/trials/v1/NCT00025506/results?page=2

API reference For AI assistants