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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer Clinical research trials and Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer  Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
For Condition: ovarian endometrioid adenocarcinoma,ovarian clear cell cystadenocarcinoma,stage 3 ovarian epithelial cancer,ovarian serous cystadenocarcinoma,ovarian undifferentiated adenocarcinoma,peritoneal cavity cancer,ovarian mixed epithelial carcinoma,ovarian mucinous cystadenocarcinoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer.
Details: OBJECTIVES: I. Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma. II. Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF SQ daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days. One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found during laparoscopy, then exploratory laparotomy must also be performed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death. PROJECTED ACCRUAL: A total of 20-41 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma Any of the following subtypes: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell carcinoma Transitional cell carcinoma Endometrioid adenocarcinoma Undifferentiated adenocarcinoma Mixed epithelial adenocarcinoma Adenocarcinoma, not otherwise specified - No ovarian carcinoma of low malignant potential (borderline) - Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting - Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease No more than 8 weeks since prior surgical debulking - Must have Hickman catheter in place or be eligible for placement - No CNS involvement --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for this malignancy - Endocrine therapy: Not specified - Radiotherapy: No radiotherapy to greater than 25% of bone marrow - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Over 18 - Performance status: GOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal No active hepatitis - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No renal failure Curatively treated ureteral obstruction allowed if above creatinine measurements met - Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmias requiring medication No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg) - Pulmonary: No significant nonneoplastic pulmonary disease - Other: No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative No other severe medical or psychiatric illness including, but not limited to the following: Acute infection Active peptic ulcer disease Uncontrolled diabetes mellitus Prior hospitalization for psychiatric illness, including severe depression or psychosis Concurrent alcohol or drug abuse
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RussellSchilder, Study Chair, Gynecologic Oncology Group
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: CDR0000067462; GOG-9903
Study Start Date: November 1999
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004221
Other Ovarian Mixed Epithelial Carcinoma Studies:
1. Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial Cancer
2. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
3. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer
4. Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
5. Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Related Studies:
Other ovarian mixed epithelial carcinoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
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