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Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer Clinical research trials and Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer  Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,ovarian mixed epithelial carcinoma,stage 3 ovarian epithelial cancer,ovarian endometrioid adenocarcinoma,ovarian undifferentiated adenocarcinoma,ovarian serous cystadenocarcinoma,Brenner Tumor,ovarian clear cell cystadenocarcinoma,ovarian mucinous cystadenocarcinoma
Status: No longer recruiting
Sponsor(s): Cytran ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile of this regimen in this patient population. III. Determine the incidence of infectious and hematologic complications in patients treated with this regimen. IV. Determine the progression-free survival of patients with no disease or minimal disease burden after initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis markers and immunologic parameters with response in patients treated with this regimen. PROTOCOL OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three IM-862 doses. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily. Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy. Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862, according to their original treatment arm. Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression. Patients are followed at 6 and 12 months. PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III ovarian epithelial cancer or primary peritoneal carcinoma of one of the following cell types: Serous adenocarcinoma; Mucinous adenocarcinoma; Clear-cell adenocarcinoma; Endometrioid; Adenocarcinoma (not otherwise specified); Undifferentiated carcinoma; Transitional cell; Malignant Brenner's tumor; Mixed epithelial carcinoma - No borderline tumor (tumor of low malignant potential) - Underwent prior standard initial cytoreductive surgery within the past 6 weeks; Optimally resected disease with no residual site of disease more than 1 cm in greatest dimension Removal of all disease extending beyond the reproductive tract; Total hysterectomy and bilateral salpingo-oopherectomy at cytoreductive surgery or in the past --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy for current malignancy; At least 5 years since prior gene therapy; At least 1 year since prior interleukin-2 (IL-2); At least 1 year since prior sargramostim (GM-CSF); Concurrent filgrastim (G-CSF) allowed; No concurrent gene therapy; No concurrent GM-CSF; No concurrent IL-2; No other concurrent angiogenesis inhibitors (e.g., thalidomide, cyclooxygenase-2 inhibitors (e.g., rofecoxib or celecoxib), interferon products, or angiotensin-converting enzyme inhibitors) - Chemotherapy: At least 5 years since prior anticancer chemotherapy; No prior chemotherapy for current malignancy; No other concurrent chemotherapy - Endocrine therapy: No prior endocrine therapy for current malignancy; At least 1 year since prior tamoxifen; No concurrent tamoxifen - Radiotherapy: No prior radiotherapy for current malignancy - Surgery: See Disease Characteristics - Other: At least 1 year since prior experimental or investigational medications; No other concurrent experimental or investigational medications --Patient Characteristics-- - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 3 times ULN; SGOT no greater than 3 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Other: No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast; No other major systemic medical illness that would preclude survival; No poor general condition or medical, social, or psychosocial factors that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PamelaPaley, Study Chair, Cytran
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center
Glendale, California, 91204
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
United States
University of Kansas School of Medicine-Wichita
Wichita, Kansas, 67214
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Women's Cancer Center - Las Vegas
Las Vegas, Nevada, 89030
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000068674; CYTRAN-IM862-302,FHCRC-5156
Study Start Date: January 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017303
Other Ovarian Endometrioid Adenocarcinoma Studies:
1. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
4. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
5. Toremifene in Treating Patients With Ovarian Cancer
Related Studies:
Other ovarian endometrioid adenocarcinoma Clinical Trials
Other Vermont Clinical Trials
Other Burlington Clinical Trials
Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
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