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ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical research trials and ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer. ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer  ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the antitumor cytostatic activity, in terms of 6-month progression-free survival, of ZD 1839 in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma. II. Determine the nature and degree of toxicity in patients treated with this drug. III. Determine the partial and complete response rates in patients treated with this drug. IV. Determine the duration of progression-free and overall survival in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily. Treatment repeats 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: Approximately 22-60 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed ovarian epithelial or primary peritoneal carcinoma; Recurrent or persistent disease - Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease - Platinum-resistant or refractory; Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR Progression during platinum-containing regimen OR Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen - Measurable disease; At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan, or MRI) OR At least 10 mm by spiral CT scan - At least 1 target lesion not within previously irradiated field - Ineligible for higher priority GOG protocol --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior immunological agents; No concurrent anti-cancer immunotherapy - Chemotherapy: See Disease Characteristics; No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent disease; No prior non-cytotoxic chemotherapy for recurrent or persistent disease; At least 3 weeks since prior chemotherapy and recovered; No concurrent anti-cancer chemotherapy - Endocrine therapy: At least 1 week since prior anti-cancer hormonal therapy; Concurrent hormone replacement therapy allowed; No concurrent anti-cancer hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy to target lesion; No prior radiotherapy to more than 25% of marrow-bearing areas; No concurrent anti-cancer radiotherapy - Surgery: At least 3 weeks since prior surgery and recovered - Other: No prior ZD 1839; No prior anti-cancer therapy that would preclude study; No concurrent chlorpromazine; No other concurrent investigational agents; No concurrent antineoplastic agents; No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or St. John's Wort --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least lower limit of normal - 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; No myocardial infarction within the past 6 months; Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No sensory or motor neuropathy greater than grade 1; No active corneal disease (e.g., keratoconjunctivitis); No active infection requiring antibiotics; No evidence of bowel dysfunction that could be related to early bowel obstruction; No other prior malignancy within the past 5 years except non-melanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RussellSchilder, Study Chair, Gynecologic Oncology Group
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Medical Oncology Clinical Research Unit
Bethesda, Maryland, 20892
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
Australia
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000068852; GOG-0170C
Study Start Date: August 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023699
Other Peritoneal Cavity Cancer Studies:
1. Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
2. Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
3. UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
4. Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other New York Clinical Trials
Other Brooklyn Clinical Trials
ZD 1839 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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