Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

NCT ID: NCT00025506

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2013-01-31

Brief Summary

This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Detailed Description

OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the partial and complete response rates in patients treated with this drug.

II. Determine the duration of PFS and overall survival of patients treated with this drug.

III. Determine the effect of this drug on initial performance status and histological grade in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., PFS) in patients treated with this drug.

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.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Thalidomide

Intervention Type: DRUG

Given orally

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Thalidomide

Given orally

Intervention Type: DRUG

Other Intervention Names

(+)-Thalidomide; (-)-Thalidomide; .alpha.-Phthalimidoglutarimide; 2, 6-Dioxo-3-phthalimidopiperidine; Alpha-Phthalimidoglutarimide; Contergan; Distaval; Kevadon; N-(2,6-Dioxo-3-piperidyl)phthalimide; N-Phthaloylglutamimide; N-Phthalylglutamic Acid Imide; Neurosedyn; Pantosediv; Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-; Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-; Sedalis; Sedoval K-17; Softenon; Synovir; Talimol; Thalomid

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed uterine sarcoma

• Carcinosarcoma (malignant mixed müllerian tumor)

• Homologous or heterologous type
• Recurrent or persistent with documented disease progression after prior local therapy
• At least 1 unidimensionally measurable target 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
• Tumors within a previously irradiated field are considered non-target lesions
• Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
• No documented brain metastases since diagnosis of cancer

• Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population
• Performance status - GOG 0-2 if received 1 prior therapy regimen
• Performance status - GOG 0-1 if received 2 prior therapy 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 at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
• No seizure disorders since diagnosis of cancer

• Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
• No active infection requiring antibiotics
• No greater than grade 1 sensory or motor neuropathy
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• At least 3 weeks since prior immunologic agents for uterine sarcoma
• No prior thalidomide
• See Disease Characteristics
• At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
• No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
• No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma
• No concurrent bisphosphonates (e.g., zoledronate)
• At least 1 week since prior hormonal therapy for uterine sarcoma
• Concurrent hormone replacement therapy allowed
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas
• See Disease Characteristics
• Recovered from prior surgery
• At least 3 weeks since any other prior therapy for uterine sarcoma
• No prior anticancer therapy that would preclude study

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. McMeekin

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02421

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000068967

Identifier Type: -

Identifier Source: secondary_id

GOG-0230B

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0230B

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02421

Identifier Type: -

Identifier Source: org_study_id