Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Recurrent Uterine Corpus Carcinoma Clinical Trial

Official title:

A Phase II Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027690
• Other study ID #: NCI-2012-02429
• Secondary ID: NCI-2012-02429CD
• Status: Completed
• Phase: Phase 2
• Start date: June 2002
• Est. completion date: July 2013

Study information

• Verified date: July 2019
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2013
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Recurrent Uterine Corpus Carcinoma

Intervention

Drug:
• Gefitinib
Given orally

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients alive and progression-free		6 months
Primary	Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0		Up to 5 years
Secondary	Duration of progression-free survival		Up to 5 years
Secondary	Duration of overall survival		Up to 5 years
Secondary	Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria		Up to 5 years
Secondary	Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)		Baseline to end of course 5
Secondary	Initial performance status and histological grade		Baseline to end of course 5