search
Back to results

Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Primary Purpose

Recurrent Uterine Corpus Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gefitinib
Laboratory Biomarker Analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Uterine Corpus Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (gefitinib)

Arm Description

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Proportion of patients alive and progression-free
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0

Secondary Outcome Measures

Duration of progression-free survival
Duration of overall survival
Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)
Initial performance status and histological grade

Full Information

First Posted
December 7, 2001
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00027690
Brief Title
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title
A Phase II Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Corpus Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (gefitinib)
Arm Type
Experimental
Arm Description
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
ZD 1839
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Proportion of patients alive and progression-free
Time Frame
6 months
Title
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Duration of progression-free survival
Time Frame
Up to 5 years
Title
Duration of overall survival
Time Frame
Up to 5 years
Title
Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame
Up to 5 years
Title
Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)
Time Frame
Baseline to end of course 5
Title
Initial performance status and histological grade
Time Frame
Baseline to end of course 5

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Leslie
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

We'll reach out to this number within 24 hrs