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

NCT00025220 | Completed Phase 2

• 5 other identifiers: NCI-2012-02415CDR0000068939GOG-0231-BGOG-0231BU10CA027469
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Corpus Leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  6 months

• Frequency and severity of adverse effects as assessed by CTC

  Up to 7 years

Secondary Outcomes (3)

• Duration of progression-free survival

  Up to 7 years

• Duration of overall survival

  Up to 7 years

• Frequency of clinical response (partial and complete response)

  Up to 7 years

Study Arms (1)

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.

Drug: Thalidomide; Other: Laboratory Biomarker Analysis

Interventions

Thalidomide DRUG

Given PO

Also known as: THAL

Treatment (thalidomide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (thalidomide)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Thalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• D. McMeekin

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: July 1, 2008
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)