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A Phase II Trial Of ZD 1839 (IRESSA) (NSC #715055, IND #61187) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Endometrial Carcinoma

Thank you

Trial Information

A Phase II Trial Of ZD 1839 (IRESSA) (NSC #715055, IND #61187) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients alive and progression-free

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Kimberly Leslie

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02429

NCT ID:

NCT00027690

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Recurrent Endometrial Carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103