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Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
This study is ongoing, but not recruiting participants.
First Received: December 7, 2001   Last Updated: July 21, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027690
  Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: gefitinib
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of ZD 1839 (IRESSA) (NSC #715055, IND #61187) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

Resource links provided by NLM:


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

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib.
  • Determine the nature and degree of toxicity of this drug in these patients.
  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the effects of this drug on the levels of epidermal growth factor receptors (EGFR), c-ErbB2 (HER-2/neu) receptors, estrogen receptors (ER), and progesterone receptors (PR) (both PR and PRB) in tumor specimens of these patients.
  • Determine if an association exists between the levels of EGFR, ER, PR, PRB, and HER-2/neu serum concentrations of gefitinib, gefitinib activity, and soluble EGFR and clinical outcome in patients treated with this drug.
  • Determine the frequency of clinical response (partial and complete response) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib 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 22-60 patients will be accrued for this study within 2.5-6 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary endometrial carcinoma

    • Recurrent or persistent disease
  • Received 1 prior chemotherapy regimen for endometrial carcinoma

    • Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI) OR
    • At least 10 mm by spiral CT scan
    • Must have at least 1 target lesion for response assessment
    • Tumors within a previously irradiated field are designated as non-target lesions

      • Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
  • Must have a tumor that is accessible for guided core needle or fine needle biopsy
  • Ineligible for a higher priority GOG protocol, defined as any active phase III protocol for the same patient population, if one exists

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2 (for patients who received 1 prior regimen)
  • GOG 0-1 (for patients who 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

Cardiovascular:

  • No unstable cardiac disease or myocardial infarction within the past 6 months
  • History of coronary artery disease, congestive heart failure, or dysrhythmia allowed if on a stable regimen for at least 3 months

Other:

  • No active infection requiring antibiotics
  • No active corneal disease (e.g., keratoconjunctivitis)
  • No grade 2 or greater sensory and motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No signs or symptoms of bowel dysfunction that would preclude successful ingestion of oral study medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunologic agents directed at malignant tumor
  • No concurrent anticancer immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy directed at the malignant tumor and recovered
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • No concurrent anticancer chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at malignant tumor
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
  • No concurrent anticancer radiotherapy

Surgery:

  • At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered

Other:

  • At least 3 weeks since any other prior therapy directed at malignant tumor
  • One additional prior cytotoxic regimen for recurrent or persistent disease allowed
  • No prior gefitinib or other epidermal growth factor receptor inhibitor
  • No prior cancer treatment that would contraindicate study therapy
  • No concurrent CYP 3A4 inducers (including phenytoin, carbamazepine, barbiturates, nafcillin, rifampin, or Hypericum perforatum [St. John's Wort])
  • No other concurrent investigational or antineoplastic agents
  • No concurrent chlorpromazine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027690

Locations
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, New Mexico
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131-5286
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Kimberly K. Leslie, MD University of New Mexico
  More Information

Additional Information:
Publications:
Leslie KK, Sill MW, Darcy KM, et al.: Efficacy and safety of gefitinib and potential prognostic value of soluble EGFR, EGFR mutations, and tumor markers in a Gynecologic Oncology Group phase II trial of persistent or recurrent endometrial cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-e16542, 2009.

Study ID Numbers: CDR0000069057, GOG-0229C
Study First Received: December 7, 2001
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00027690     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Genital Neoplasms, Female
Uterine Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms
Gefitinib

ClinicalTrials.gov processed this record on November 27, 2009