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

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ClinicalTrials.gov Identifier: NCT00025220
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Condition or disease Intervention/treatment Phase
Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma Drug: Thalidomide Other: Laboratory Biomarker Analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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 leiomyosarcoma.

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

V. Determine the effect of this drug on initial performance status in these patients.

VI. 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.

VII. 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Study Start Date : September 2001
Actual Primary Completion Date : April 2003
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (thalidomide)
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Thalidomide
Given PO
Other Name: THAL
Other: Laboratory Biomarker Analysis
Correlative studies



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
  2. Frequency and severity of adverse effects as assessed by CTC [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. Duration of progression-free survival [ Time Frame: Up to 7 years ]
  2. Duration of overall survival [ Time Frame: Up to 7 years ]
  3. Frequency of clinical response (partial and complete response) [ Time Frame: Up to 7 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
  • 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
  • No prior thalidomide
  • At least 3 weeks since prior immunologic agents for uterine LMS
  • 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
  • At least 1 week since prior hormonal therapy for uterine LMS
  • Concurrent hormone replacement therapy allowed
  • At least 3 weeks since prior radiotherapy for uterine LMS and recovered
  • No prior radiotherapy to more than 25% of bone marrow
  • Recovered from recent prior surgery
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025220


Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: D. McMeekin Gynecologic Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025220     History of Changes
Other Study ID Numbers: NCI-2012-02415
NCI-2012-02415 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068939
GOG-0231-B ( Other Identifier: Gynecologic Oncology Group )
GOG-0231B ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: December 2012

Additional relevant MeSH terms:
Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents