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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025220
First received: October 11, 2001
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Recurrent Uterine Sarcoma
Uterine Leiomyosarcoma
Drug: thalidomide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTC [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response (partial and complete response) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2001
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025220

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: D. Scott McMeekin Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025220     History of Changes
Other Study ID Numbers: NCI-2012-02415, GOG-0231-B, U10CA027469, CDR0000068939
Study First Received: October 11, 2001
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014