Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00027690
First received: December 7, 2001
Last updated: June 10, 2014
Last verified: December 2012
  Purpose

Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer.


Condition Intervention Phase
Recurrent Endometrial Carcinoma
Drug: gefitinib
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 Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients alive and progression-free [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR) [ Time Frame: Baseline to end of course 5 ] [ Designated as safety issue: No ]
  • Initial performance status and histological grade [ Time Frame: Baseline to end of course 5 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2002
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: gefitinib
Given orally
Other Names:
  • Iressa
  • ZD 1839
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.

IV. 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.

V. 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.

VI. 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

Inclusion Criteria:

  • 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)
    • 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
  • Performance status - GOG 0-2 (for patients who received 1 prior regimen)
  • Performance status - GOG 0-1 (for patients who received 2 prior 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
  • 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
  • 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
  • At least 3 weeks since prior immunologic agents directed at malignant tumor
  • No concurrent anticancer immunotherapy
  • 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
  • At least 1 week since prior hormonal therapy directed at malignant tumor
  • No concurrent anticancer hormonal therapy
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
  • No concurrent anticancer radiotherapy
  • At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered
  • 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
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: NCT00027690

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Kimberly Leslie Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027690     History of Changes
Other Study ID Numbers: NCI-2012-02429, NCI-2012-02429, CDR0000069057, GOG-0229C, GOG-0229C, U10CA027469
Study First Received: December 7, 2001
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014