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Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer clinical trial. Human subjects often get the best healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer  Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
For Condition: peritoneal cavity cancer,stage 3 ovarian epithelial cancer,Fallopian Tube Cancer,stage 4 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating ovarian epithelial, fallopian tube, or peritoneal cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer.
Details: OBJECTIVES: - Compare the time to disease relapse in patients with stage III or IV ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma treated with monoclonal antibody B43.13 vs placebo. - Compare the survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the immune response in patients treated with these regimens. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive monoclonal antibody B43.13 IV over 20 minutes on weeks 0, 4, 8, and 20 and then every 12 weeks thereafter for up to 5 years from the week 0 dose. - Arm II: Patients receive placebo IV over 20 minutes on weeks 0, 4, 8, and 20 and then every 12 weeks thereafter for up to 5 years from the week 0 dose. Treatment in both arms continues in the absence of disease relapse or unacceptable toxicity. Quality of life is assessed at weeks 0, 8, 20, 32, 44, 56, 68, 80, 92, and 104 and then when the patient leaves the study. Patients are followed every 3 months for 7 years from study entry. PROJECTED ACCRUAL: A total of 177 patients (118 for arm I and 59 for arm II) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma - Stage III or IV - Microscopic or small-diameter residual disease after primary debulking surgery - No more than 1 interval debulking procedure - Elevated serum CA 125 prior to or at surgery - If pre-surgical CA 125 is not available, patients must have a serum CA 125 at least 100 U/mL and strong tumor tissue expression - Previously treated with front-line platinum- and taxane-based chemotherapy within the past 4-12 weeks - Serum CA 125 level no greater than 65 U/mL prior to third course of front-line therapy - No more than 8 courses - No more than 1 prior chemotherapy regimen - Complete clinical response to prior front-line chemotherapy and surgery, defined as the following: - Normal physical examination - No conclusive evidence of residual tumor by CT scan of the abdomen and pelvis - Normal chest x-ray - Serum CA 125 level at least 5 U/mL, but less than 35 U/mL - No evaluable disease - No refractory or recurrent ovarian epithelial, fallopian tube, or peritoneal adenocarcinoma requiring chemotherapy - No tumors of low-malignant potential or noninvasive disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Neutrophil count at least 1,000/mm^3 - Lymphocyte count at least 300/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.0 g/dL Hepatic - Bilirubin no greater than 5 times upper limit of normal (ULN) - Lactate dehydrogenase no greater than 2 times ULN - SGOT and SGPT no greater than 2 times ULN - Albumin at least 3.5 g/dL - No hepatitis Renal - Creatinine no greater than 1.6 mg/dL Cardiovascular - No uncontrolled hypertension - No New York Heart Association class II-IV congestive heart failure - No uncontrolled angina - No uncontrolled arrhythmias - No significant cardiovascular abnormalities Immunologic - HIV negative - No immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinema, or dysgammaglobulinema or acquired, hereditary, or congenital immunodeficiencies - No active autoimmune disease, including any of the following: - Rheumatoid arthritis - Systemic lupus erythematosus - Ulcerative colitis - Crohn's disease - Multiple sclerosis - Ankylosing spondylitis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other uncontrolled disease - Well-controlled chronic disease (e.g., diabetes mellitus or hypertension) allowed - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No contraindications to pressor agents - No recent history of alcoholism or drug abuse - No active febrile infection - No known allergy to murine proteins - No prior documented anaphylactic reaction to any drug - No known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure - No concurrent illness that would preclude study completion or mask an adverse reaction PRIOR CONCURRENT THERAPY: Biologic therapy - More than 6 weeks since prior biological response modifiers, interferons, tumor necrosis factor, other cytokines (e.g., interleukins), or BCG vaccine - Prior hematopoietic growth factors allowed Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy - No concurrent mercaptopurine or methotrexate - No other concurrent anticancer chemotherapy Endocrine therapy - No concurrent systemic corticosteroids (e.g., dexamethasone or prednisone) - Inhaled corticosteroids for asthma allowed - Topical corticosteroids allowed - No concurrent adrenocorticotropic hormone Radiotherapy - More than 4 weeks since prior radiotherapy to the whole abdomen, abdominopelvis, or pelvis Surgery - See Disease Characteristics - More than 4 weeks since prior surgery - No prior splenectomy Other - At least 30 days since prior investigational drugs - No concurrent immunosuppressive drugs - No concurrent cyclosporine - No other concurrent antineoplastic drugs - No concurrent azathioprine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanBerek, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
Additional Information:
Study ID Numbers: CDR0000321925; UCLA-0211008,UNITHER-OVA-Gy-17(A)
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068354
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
2. Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
3. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
4. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
5. Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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