search
Back to results

Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

Primary Purpose

Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Adenoacanthoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (thalidomide)

Arm Description

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Proportion of patients alive and progression-free
Frequency of adverse events assessed by CTC

Secondary Outcome Measures

Progression-free survival
Overall survival
Frequency of clinical response using the GOG RECIST criteria

Full Information

First Posted
October 11, 2001
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00025467
Brief Title
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Official Title
A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (thalidomide)
Arm Type
Experimental
Arm Description
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
Kevadon, Synovir, THAL, Thalomid
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Proportion of patients alive and progression-free
Time Frame
6 months
Title
Frequency of adverse events assessed by CTC
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
From study entry until disease progression, death, or date of last contact, assessed up to 6 years
Title
Overall survival
Time Frame
From entry into the study to death or the date of last contact, assessed up to 6 years
Title
Frequency of clinical response using the GOG RECIST criteria
Time Frame
Up to 6 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Scott McMeekin
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

We'll reach out to this number within 24 hrs