Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Carcinoma

In brief

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.

Key facts

Study ID

NCT00027690

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2002-06-01

Expected to finish

2013-07-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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