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Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study has been completed.
First Received: October 11, 2001   Last Updated: July 23, 2008   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: 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:
Study ID Numbers: CDR0000068964, GOG-0229-B
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025467     History of Changes
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 carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:
Anti-Infective Agents
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
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 09, 2009