Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00025467

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Adenoacanthoma Endometrial Adenocarcinoma Endometrial Adenosquamous Cell Carcinoma Endometrial Clear Cell Carcinoma Endometrial Papillary Serous Carcinoma Recurrent Endometrial Carcinoma	Drug: thalidomide Other: laboratory biomarker analysis	Phase 2

Detailed Description

OBJECTIVES:

Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma.
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.
Determine the duration of progression-free and overall survival in patients treated with this drug.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (thalidomide) 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 Given orally Other Names: Kevadon Synovir THAL Thalomid Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

Experimental: Treatment (thalidomide)

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

Given orally

Other Names:

Kevadon

Synovir

THAL

Thalomid

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Proportion of patients alive and progression-free [6 months]
Frequency of adverse events assessed by CTC [Up to 6 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)