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

NCT00025506 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-02421CDR0000068967GOG-0230BU10CA027469
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Every other cycle for 6 months

• 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 Outcomes (5)

• Progression Free Survival

  Every other cycle until progression or death, up to 5 years.

• 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)

• Overall Survival

  From study entry to death or last contact, up to 5 years.

• Initial Performance Status

  baseline

• Initial Histologic Grade

  Baseline

Other Outcomes (2)

• Serum and Plasma Concentrations of VEGF and bFGF With PFS

  Up to 5 years

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

  Up to 5 years

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis; Drug: Thalidomide

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (thalidomide)

Thalidomide DRUG

Given orally

Also known as: (+)-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, Pantosediv, Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-, Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-, Sedalis, Sedoval K-17, Softenon, Synovir, Talimol, Thalomid

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 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

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

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• D. McMeekin

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 24, 2019
• Results First Posted: May 27, 2015

Record last verified: 2019-07

Locations

US (1)