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Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer Clinical research trials and Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer. Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer clinical trial. Human subjects often get the best healthcare possible for their Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer  Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
For Condition: Ovarian Neoplasms,Cervix Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of the experimental drug ZD1839 (also known as Iressa® (Registered Trademark) or gefitinib) for treating patients with advanced ovarian or cervical cancer with or without fallopian tube or primary peritoneal cancer. ZD1839 attacks a group of proteins called epidermal growth factor receptor (EGFR) proteins. These proteins are found on the surface of some cancer cells and some normal cells and may help tumor cells grow and spread to other parts of the body. In laboratory experiments, ZD1839 slowed the growth of certain cancers, and in preliminary studies in humans, a small number of women with ovarian cancer who took ZD1839 had no tumor growth for the period of time they received the drug. This study will determine whether ZD1839 can cause tumors to shrink or stabilize in some patients with ovarian or cervical cancer. It will also look for tumor characteristics that may indicate which ones are more likely to respond to treatment with ZD1839. Women 18 years of age or older with ovarian or cervical cancer whose cancer persists or has relapsed after undergoing at least one operation and one course of chemotherapy or radiotherapy may be eligible for this study. Patients with fallopian tube or primary peritoneal cancer may also participate. Candidates will be screened with a medical history, physical examination, blood and urine tests, and a computerized tomography (CT) scan to locate the tumor and determine biopsy sites (see below). Participants will take ZD1839 tablets by mouth once a day. They will keep a diary of when they take the medicine and record any side effects they may experience. In addition, they will have the following tests and procedures: - CT scan before starting treatment and again every 8 weeks to monitor tumor size. - Tumor biopsies before starting treatment and about 4 weeks into the study to look for characteristics unique to the patient's tumor that might make it more likely to respond to ZD1839. Tumor biopsies will be done using a needle or by direct visualization using laparoscopy. For the needle biopsy, the area of the procedure is anesthetized and a small needle is inserted through the skin into the tumor. A piece of tissue smaller than the size of a pin is withdrawn through the needle. The needle biopsy is done under CT guidance, allowing the radiologist to see exactly where to place the needle. Laparoscopy is a surgical procedure, performed under sedation or general anesthesia, that is done if the tumor is in a place that cannot be reached with a needle through the skin. It requires making two small holes in the skin through which tubes are inserted to locate the tumor and cut out a small piece of tissue. - Skin biopsies before starting treatment and about 4 weeks into the study to determine the effect of ZD1839 on EGFR. The skin biopsies use a cookie cutter-like instrument to obtain two pieces of skin the size of a grain of rice. - Follow-up visits every 4 weeks or more often, as needed, for a physical examination and blood tests, and review of laboratory studies and drug side effects. Patients whose tumor stops growing or shrinks and who do not have serious drug side effects may continue to receive treatment. Those whose cancer worsens or who develop severe drug side effects will be taken off the study, referred back to their local physician, and counseled about other NCI trials for which they may be eligible or options outside NCI that may be available to them.
Details: This is a phase II pilot study to evaluate the safety and efficacy of the EGFR inhibitor, ZD1839 (Iressa; Gefitinib) in patients with persistent or recurrent epithelial ovarian cancer and cervical cancer. The primary objective is to demonstrate the ability of ZD1839 to decrease activation of the EGFR, AKT, and ERK pathways in each tumor type. The secondary objectives are to demonstrate ZD1839-induced modulation of tumor signal transduction pathway profiles from sentinel tumor and skin biopsies, to demonstrate changes in these pathways EGFR using microproteomic tissue lysate array technology, and to determine clinical activity and toxicity in the above cohorts. EGFR inhibitory agent, ZD1839, will be administered to the two cohorts and serial tumor and non-affected skin samples will be obtained. The correlation between tumor signal pathway profile and patient outcome with EGFR expression and kinase activity will be studied.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients 18 years and older with biopsy-proven epithelial ovarian cancer or cervical cancer that is relapsed and/or refractory to prior therapy will be eligible. Patients with cancers of the fallopian tubes, primary peritoneum, or low malignant potential with an invasive recurrence will be included in the ovarian cancer cohort. For a first relapse of ovarian cancer, patients with a disease free interval greater than 12 months may be enrolled only after full informed consent outlining alternative treatment is completed. Histopathologic diagnosis must be confirmed in the Laboratory of Pathology (LP), NCI. A block or re-cuts of the primary is required. If this is unavailable, a recent resection specimen of a metastatic site is required for entry. All patients must have measurable disease (by RECIST criteria) and a sentinel lesion adequate for core biopsy either through percutaneous biopsy or laparoscopy to be eligible. All patients must be willing to undergo punch biopsies of unaffected skin. Patients must have a performance status: ECOG &eq; 0, 1 or 2. Patients must have good end organ function: WBC greater than 3000/mm(3), platelets greater than 100,000/mm(3), normal acute care panel with serum creatinine less than 1.5 mg/dl, liver function tests (AST and ALT) within 2.5 times the upper limit of normal, and bilirubin less than 1.5 mg/dl. Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy). Mitomycin and nitrosoureas must be stopped at least 6 weeks prior to enrollment. Date of last prior therapy will be reported in the research record. All patients must have recovered from any toxicity related to prior therapy to NCI/CTEP grade 1. The effects of ZD1839 on the developing human fetus are unknown. Women of childbearing age and potential must agree to use adequate contraception prior to study entry and during therapy and continue for 2 months after completion of therapy. Patients must be able to give written informed consent. All patients must be registered by calling the ORKAND Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST. EXCLUSION CRITERIA: Patients who have received other EGFR inhibitory agents such as OSI774, Cetuximab (IMC225), or Abgenics (anti-EGFR) will be excluded. Evidence of CNS involvement (patients with abnormal clinical exam or history will require a head CT or MRI). History of myocardial infarction or unstable dysrhythmia within six months of entry. History of another invasive malignancy in the last five years. Noninvasive, non-melanoma skin cancers will be allowed. Patients with active infection will not be eligible, but may be eligible once infection has resolved. Pregnant women and those who are actively breast-feeding will be excluded because of possible risks to the fetus or infant. There is limited data on drug interactions between ZD1839 and antiretroviral therapy. As such, patients requiring these medications are excluded from study because safety cannot be confirmed due to risk of drug interactions with ZD1839 or other agents administered during the study. No concomitant use of complementary or alternative medication or other agents (investigational or anti-cancer agents) will be allowed without approval of a PI or AI. Every effort will be made to maximize patient safety and minimize changes in chronic medications. Medications altering metabolism of ZD1839 with potential toxicity will be allowed only at the PI's discretion. Patients receiving itraconazole, ketoconazole, erythromycin, verapamil, tamoxifen, chlorpromazine, amiodarone, and chloroquine will not be eligible for this study. Patients receiving concomitant drugs known to induce CYP3A4 enzymes, specifically phenytoin, carbamazepine, rifampicin, barbiturates, oxacarbazepine, rifapentine, or St. John's Wort will not be ineligible as studies have shown that plasma concentrations may be below those thought to be biologically active. Patients with incomplete healing from previous oncologic or other major surgery and those with active ocular inflammation/infection will be ineligible.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020303; 02-C-0303
Study Start Date: September 11, 2002
Record last reviewed: July 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046007
Other Ovarian Neoplasms Studies:
1. Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
2. Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
3. Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer
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Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
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