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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Clinical research trials and Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance 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 Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer  Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: recurrent ovarian epithelial cancer,peritoneal cavity cancer,fallopian tube cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Herbert Irving Comprehensive 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 and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer, fallopian tube , or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide phosphate as a component of a multicourse high dose chemotherapy regimen supported by peripheral blood stem cell transplantation in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Evaluate the response, time to progression, disease free survival, and overall survival in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of topotecan. All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy. Subcutaneous filgrastim (G-CSF) is given beginning 24 hours after induction dose. Following induction therapy, peripheral blood stem cells (PBSC) are harvested. After patients receive high dose paclitaxel and carboplatin chemotherapy, a portion of the PBSC are reinfused. When patients recover from the paclitaxel/carboplatin chemotherapy the administration of topotecan and etoposide phosphate begins. Topotecan is administered, as a 72 hour continuous infusion, according to a dose escalation schedule with a fixed dose of etoposide phosphate. A second portion of PBSC are reinfused after topotecan/etoposide phosphate chemotherapy. A course of thiotepa is given along with the final portion of PBSC after treatment with topotecan and etoposide phosphate. Dose escalation of topotecan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year and every 4 months thereafter to determine progression free and overall survival. PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for the phase I portion of this study, and 25 more patients will be accrued for the phase II portion.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer following at least 3 courses of initial standard platinum based chemotherapy OR have radiologic evidence of recurrence with a CA125 greater than 100 - Initial stage IV disease having a complete response following platinum based therapy allowed - No brain metastases - Not eligible for other high priority national or institutional study --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No concurrent acetaminophen --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 2 months Hematopoietic: - WBC greater than 3000/mm3 - Absolute neutrophil count greater than 1500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 1.5 times normal - SGOT or SGPT less than 1.5 times normal - PT/PTT within normal limits Renal: - BUN less than 1.5 times normal - Creatinine less than 1.5 times normal - Creatinine clearance greater than 55 mL/min Cardiovascular: LVEF at least 45% Other: - Not pregnant or nursing HIV negative - No prior malignancy other than curatively treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or breast cancer if the risk of recurrence is sufficiently low - No serious illness that would prevent treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmyTiersten, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000065734; CPMC-IRB-7866,NCI-G97-1327
Study Start Date: January 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003064
Other Fallopian Tube Cancer Studies:
1. Quality-of-Life Assessment in Patients With Ovarian Cancer
2. Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum
3. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
4. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
Related Studies:
Other fallopian tube cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
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