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Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
This study has been completed.
First Received: October 11, 2001   Last Updated: August 6, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025220
  Purpose

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus.


Condition Intervention Phase
Sarcoma
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evalutaion of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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 leiomyosarcoma.
  • Determine the nature and degree of the toxicity of this drug in these patients.
  • Determine the partial and complete response rates in patients treated with this drug.
  • Determine the duration of PFS and overall survival of patients treated with this drug.
  • Determine the effect of this drug on initial performance status in these patients.
  • Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
  • Assess the association of endogenous angiogenesis factors with clinical outcome (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 4 weeks 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 22-60 patients will be accrued for this study within 7-21 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments

    • Recurrent or persistent disease
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
    • Tumors within a previously irradiated field are considered non-target lesions
  • No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
  • Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
  • Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population
  • No documented brain metastases since diagnosis of cancer

    • Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2 if received 1 prior therapy regimen
  • GOG 0-1 if received 2 prior therapy regimens

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min

Other:

  • No documented 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 prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior thalidomide
  • At least 3 weeks since prior immunologic agents for uterine LMS

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since other prior chemotherapy for uterine LMS and recovered
  • No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine LMS
  • No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for uterine LMS
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for uterine LMS and recovered
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • See Disease Characteristics
  • Recovered from recent prior surgery

Other:

  • No prior anticancer therapy that would preclude study therapy
  • At least 3 weeks since other prior therapy for uterine LMS
  • No concurrent bisphosphonates (e.g., zoledronate)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025220

  Show 36 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068939, GOG-0231-B
Study First Received: October 11, 2001
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00025220     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent uterine sarcoma
uterine leiomyosarcoma

Study placed in the following topic categories:
Immunologic Factors
Thalidomide
Leiomyosarcoma
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Angiogenesis Inhibitors
Immunosuppressive Agents
Recurrence
Genital Diseases, Female
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Uterine Sarcoma
Sarcoma
Uterine Neoplasms

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Genital Diseases, Female
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Site
Therapeutic Uses
Sarcoma
Uterine Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on July 02, 2009