|
Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy healthcare trials take place in a lot of 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 assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy. Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy clinical trial. Human subjects often obtain the finest healthcare possible for their Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy  Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
For Condition: stage 4 ovarian epithelial cancer,peritoneal cavity cancer,stage 3 ovarian epithelial cancer,stage 1 ovarian epithelial cancer,stage 2 ovarian epithelial cancer
Status: No longer 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 more effective than observation for ovarian cancer or primary peritoneal cancer that is in remission. PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy.
Details: OBJECTIVES: - Determine the efficacy of yttrium Y 90 monoclonal antibody HMFG1, in terms of survival, in patients with ovarian epithelial carcinoma in remission after debulking surgery and platinum-based chemotherapy. - Determine the toxicity and tolerability of this treatment regimen in these patients. - Determine the quality of life of patients treated with this regimen. - Evaluate this treatment regimen, in terms of the time to relapse, ECOG performance status, frequency of hospitalization, changes in concurrent medication, and incidence and severity of adverse events, in this patient population. OUTLINE: This is a randomized, parallel, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive standard therapy (observation). - Arm II: After imaging studies of the peritoneal cavity to verify adequate fluid distribution, patients receive yttrium Y 90 monoclonal antibody HMFG1 intraperitoneally over 1 minute. Quality of life is assessed in all patients prior to randomization, at weeks 4 and 8, at 3 months, and then every 3 months thereafter. Patients in arm I are followed at weeks 1, 4, and 8. Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12. All patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 420 patients (210 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage IC, II, III, or IV ovarian epithelial carcinoma or primary peritoneal serous carcinoma - Prior complete response to 1 platinum-based chemotherapy regimen consisting of at least 5 courses - Absence of disease on physical and radiological exam (CT scan/MRI) - CA 125 normal - No visible evidence of malignant disease on second-look laparoscopy - No disease relapse even if complete response to a second course of chemotherapy - Prior bilateral oophorectomy with or without salpingectomy, omentectomy, and total or partial abdominal hysterectomy required - No known metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - SGOT/SGPT no greater than 2 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Other: - No other malignancy except basal cell skin cancer - No serious physical or psychiatric disease that would preclude study entry - No significant loculation that would preclude good distribution of study medication - Human antimouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior murine antibody Chemotherapy: - See Disease Characteristics - No more than 4-8 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent participation in other trials involving adjuvant cancer treatment - No other concurrent experimental therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanBerek, Study Chair, Jonsson Comprehensive Cancer Center
Antisoma
London, England, W5 3QR
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067341; UCLA-9712040,ANTISOMA-SMART22,NCI-G99-1604
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004115
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
2. Biological Therapy in Treating Patients With Advanced Cancer
3. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
4. Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
5. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
|
|
|
|
|
|
|
|
