NCT00006005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 21, 2013

Status Verified

August 1, 2004

First QC Date

July 5, 2000

Last Update Submit

June 20, 2013

Conditions

Endometrial CancerSarcoma

Keywords

stage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcomauterine carcinosarcomauterine leiomyosarcomaendometrial stromal sarcoma

Interventions

thalidomideDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

St. Luke's-Roosevelt Hospital Center - Roosevelt Division

New York, New York, 10019, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Endometrial NeoplasmsSarcomaSarcoma, Endometrial Stromal

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Complex and MixedEndometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Scott Wadler, MD

    Weill Medical College of Cornell University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

September 1, 2000

Study Completion

August 1, 2006

Last Updated

June 21, 2013

Record last verified: 2004-08

Locations

US(10)