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Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025506
  Purpose

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

PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with recurrent or persistent carcinosarcoma of the uterus.


Condition Intervention Phase
Sarcoma
Drug: thalidomide
Phase II

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients alive at 6 months [ Designated as safety issue: No ]
  • Progression-free survival (PFS) at 6 months [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTC [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of clinical response as assessed by GOG RECIST criteria [ Designated as safety issue: No ]
  • Duration of overall survival and PFS [ Designated as safety issue: No ]
  • Initial performance status and histological grade [ Designated as safety issue: No ]
  • Serum and plasma concentrations of vascular endothelial growth factor (VEGF) and bFGF [ Designated as safety issue: No ]
  • Serum and plasma concentrations of VEGF and bFGF with PFS [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: September 2001
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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 and histological grade in these patients.
  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine sarcoma

    • Carcinosarcoma (malignant mixed mullerian 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 OR
    • 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

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:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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)

Endocrine therapy:

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

Radiotherapy:

  • 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

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • At least 3 weeks since any other prior therapy for uterine sarcoma
  • No prior anticancer therapy that would preclude study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025506

  Show 59 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068967, GOG-0230B
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025506     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Anti-Infective Agents
Immunologic Factors
Thalidomide
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
Carcinosarcoma

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

ClinicalTrials.gov processed this record on September 02, 2009