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

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma

In brief

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.

Key facts

Study ID

NCT00025506

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2001-09-01

Expected to finish

2013-01-01

Last updated by the study team

2019-07-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• Creatinine clearance greater than 60 mL/min
• Not pregnant
• Negative pregnancy test
• Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
• No seizure disorders since diagnosis of cancer

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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