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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Clinical research trials and Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer  Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: ovarian mixed epithelial carcinoma,stage 3 ovarian epithelial cancer,peritoneal cavity cancer,ovarian clear cell cystadenocarcinoma,stage 4 ovarian epithelial cancer,ovarian undifferentiated adenocarcinoma,ovarian mucinous cystadenocarcinoma,Fallopian Tube Cancer,ovarian endometrioid adenocarcinoma,ovarian serous cystadenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
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 plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine pathological complete response rate in patients with suboptimally debulked stage III or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma treated with sequential paclitaxel, carboplatin, and topotecan with peripheral blood stem cell rescue. II. Determine disease free and overall survival of these patients. PROTOCOL OUTLINE: Patients receive mobilization with cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Filgrastim (G-CSF) is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose sequential chemotherapy begins 21 days after leukapheresis. Patients receive paclitaxel IV over 24 hours on day 1, carboplatin IV over 2 hours on day 2, and then topotecan IV over 24 hours. G-CSF is administered subcutaneously beginning on day 3 until blood counts recover. PBSC are reinfused on day 4. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy. PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven ovarian, fallopian tube, or primary peritoneal carcinoma; Suboptimally debulked stage III (greater than 1.0 cm residual disease); Stage IV - Histological subtypes allowed include: Serous adenocarcinoma; Mucinous adenocarcinoma; Clear cell carcinoma; Transitional cell carcinoma; Endometrioid adenocarcinoma; Undifferentiated adenocarcinoma; Mixed epithelial adenocarcinoma; Adenocarcinoma not otherwise specified - No borderline ovarian carcinoma of low malignant potential histology - Stage III disease patients must have had appropriate surgery for ovarian, fallopian tube, and primary peritoneal carcinoma and retained suboptimally debulked disease (greater than 1.0 cm residual disease) - No CNS involvement --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow - Surgery: See Disease Characteristics; No greater than 8 weeks since debulking surgery --Patient Characteristics-- - Age: 18 and over - 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; AST and ALT no greater than 2 times upper limit of normal; Hepatitis negative - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; Ureteral obstruction must be successfully treated; No renal failure - Cardiovascular: No congestive heart failure; No myocardial infarction within past 6 months; No significant arrhythmias requiring medication; No poorly controlled hypertension; No poorly controlled systolic blood pressure; No diastolic blood pressure consistently greater than 100 mmHg - Pulmonary: No significant non-neoplastic pulmonary disease - Other: No other severe medical disease; HIV negative; No prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix; Second concurrent solid tumor malignancy allowed if not life threatening and if does not require chemotherapy or radiotherapy; No acute infection No active peptic ulcer disease; No uncontrolled diabetes mellitus; No current psychiatric disease, alcohol abuse, or drug abuse; No prior hospitalization for psychiatric disease including severe depression or psychosis; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No hypersensitivity to E. coli derived products
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RussellSchilder, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000067137; FCCC-98030,NCI-G99-1536
Study Start Date: August 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003944
Other Ovarian Serous Cystadenocarcinoma Studies:
1. Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
3. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
4. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
5. Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Related Studies:
Other ovarian serous cystadenocarcinoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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