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Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study has been completed.

First Received on October 11, 2001.   Last Updated on April 30, 2011   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025467
  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 endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent of Persistent Endometrial Carcinoma

Resource links provided by NLM:


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

Study Start Date: September 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma.
  • Determine the nature and degree of toxicity of this drug in these patients.
  • Determine the partial and complete response rates in patients treated with this drug.
  • Determine the duration of progression-free and overall survival in patients treated with this drug.
  • Determine the effect of this drug on initial performance status and histological grade in these patients.

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: Approximately 22-60 patients will be accrued for this study within 26 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma

    • Recurrent or persistent (refractory to curative therapy or established treatment)
    • No sarcomas
  • At least 1 unidimensionally measurable 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
  • At least 1 target lesion outside the area of prior radiotherapy
  • Received 1 prior chemotherapy regimen for endometrial carcinoma

    • Initial treatment may include high-dose therapy, consolidation, or extended therapy
    • No more than 1 additional cytotoxic regimen for recurrent or persistent disease
    • No non-cytotoxic chemotherapy for recurrent or persistent disease
  • Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population)
  • No documented brain metastases since diagnosis of cancer

    • Patients with stable CNS deficits 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 patient received 1 prior regimen
  • GOG 0-1 if patient received 2 prior 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 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study participation
  • No active infection requiring antibiotics
  • No sensory or motor neuropathy greater than grade 1
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer
  • No documented seizure disorders since diagnosis of cancer

    • Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic agents directed at malignancy
  • No prior thalidomide

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy directed at malignancy and recovered

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy directed at malignancy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

  • Recovered from prior surgery

Other:

  • At least 3 weeks since any other prior therapy directed at malignancy
  • No prior cancer therapy that would preclude study participation
  • No concurrent bisphosphonates (e.g., zoledronate)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025467

  Show 53 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025467     History of Changes
Other Study ID Numbers: CDR0000068964, GOG-0229-B
Study First Received: October 11, 2001
Last Updated: April 30, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial adenoacanthoma
endometrial papillary serous carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
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 February 09, 2012