Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

Study Overview
=================
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

Detailed Description
-----------------
OBJECTIVES: I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the partial and complete response rates in patients treated with this drug. IV. Determine the duration of progression-free and overall survival in patients treated with this drug. V. Determine the effect of this drug on initial performance status and histological grade in these patients. OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Official Title
-----------------
A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma

Conditions
-----------------
Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma

Intervention / Treatment
-----------------
* Drug: thalidomide
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study participation No active infection requiring antibiotics No sensory or motor neuropathy greater than grade 1 No other invasive malignancy within the past 5 years except non-melanoma skin cancer No documented seizure disorders since diagnosis of cancer Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen At least 3 weeks since prior biologic or immunologic agents directed at malignancy No prior thalidomide See Disease Characteristics At least 3 weeks since prior chemotherapy directed at malignancy and recovered At least 1 week since prior hormonal therapy directed at malignancy Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy directed at malignancy and recovered No prior radiotherapy to more than 25% of marrow-bearing areas Recovered from prior surgery At least 3 weeks since any other prior therapy directed at malignancy No prior cancer therapy that would preclude study participation No concurrent bisphosphonates (e.g., zoledronate)
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (thalidomide)<br>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: thalidomide<br>* Given orally<br>* Other names: Thalomid;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients alive and progression-free |  | 6 months | 
| Frequency of adverse events assessed by CTC |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |