|
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer Clinical research trials and Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer. Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer  Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
For Condition: recurrent endometrial cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer.
Details: OBJECTIVES: - Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib. - Determine the nature and degree of toxicity of this drug in these patients. - Determine the progression-free and overall survival of patients treated with this drug. - 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. - 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. - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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) OR - 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 (for patients who received 1 prior regimen) - GOG 0-1 (for patients who received 2 prior regimens) Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - 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 Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - 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 Other: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior immunologic agents directed at malignant tumor - No concurrent anticancer immunotherapy Chemotherapy: - 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 Endocrine therapy: - At least 1 week since prior hormonal therapy directed at malignant tumor - No concurrent anticancer hormonal therapy Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered - No concurrent anticancer radiotherapy Surgery: - At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimberlyLeslie, Study Chair, University of New Mexico Health Science Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131-5286
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Additional Information:
Study ID Numbers: CDR0000069057; GOG-0229C
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027690
Other Recurrent Endometrial Cancer Studies:
1. Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
2. Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
3. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
4. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
5. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Related Studies:
Other recurrent endometrial cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
|
|
|
|
|
|
|
|
