Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

Endometrial Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025467
• Other study ID #: NCI-2012-02420
• Secondary ID: GOG-0229-BU10CA0
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: January 23, 2013
• Start date: September 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Endometrial Adenoacanthoma
• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Cell Carcinoma
• Endometrial Clear Cell Carcinoma
• Endometrial Neoplasms
• Endometrial Papillary Serous Carcinoma
• Recurrent Endometrial Carcinoma
• Uterine Neoplasms

Intervention

Drug:
• thalidomide
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients alive and progression-free		6 months	No
Primary	Frequency of adverse events assessed by CTC		Up to 6 years	Yes
Secondary	Progression-free survival		From study entry until disease progression, death, or date of last contact, assessed up to 6 years	No
Secondary	Overall survival		From entry into the study to death or the date of last contact, assessed up to 6 years	No
Secondary	Frequency of clinical response using the GOG RECIST criteria		Up to 6 years	No