Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Completed · Phase 2
Conditions studied: Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma
In brief
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
Key facts
- Study ID
- NCT00025467
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2001-09-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
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
- Performance status - GOG 0-1 if patient received 2 prior 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
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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