NCT00025467

Brief Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

5.8 years

First QC Date

October 11, 2001

Last Update Submit

January 23, 2013

Conditions

Endometrial AdenoacanthomaEndometrial AdenocarcinomaEndometrial Adenosquamous Cell CarcinomaEndometrial Clear Cell CarcinomaEndometrial Papillary Serous CarcinomaRecurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients alive and progression-free

    6 months

  • Frequency of adverse events assessed by CTC

    Up to 6 years

Secondary Outcomes (3)

  • Progression-free survival

    From study entry until disease progression, death, or date of last contact, assessed up to 6 years

  • Overall survival

    From entry into the study to death or the date of last contact, assessed up to 6 years

  • Frequency of clinical response using the GOG RECIST criteria

    Up to 6 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.

Drug: thalidomideOther: laboratory biomarker analysis

Interventions

thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Treatment (thalidomide)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (thalidomide)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed endometrial carcinoma
  • Recurrent or persistent (refractory to curative therapy or established treatment)
  • No sarcomas
  • At least 1 unidimensionally measurable 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
  • At least 1 target lesion outside the area of prior radiotherapy
  • Received 1 prior chemotherapy regimen for endometrial carcinoma
  • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • No more than 1 additional cytotoxic regimen for recurrent or persistent disease
  • No non-cytotoxic chemotherapy for recurrent or persistent disease
  • Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population)
  • No documented brain metastases since diagnosis of cancer
  • Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI
  • Performance status - GOG 0-2 if patient received 1 prior regimen
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • D. Scott 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

October 15, 2003

Study Start

September 1, 2001

Primary Completion

July 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)