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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer  Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
For Condition: recurrent ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have ovarian epithelial cancer.
Details: OBJECTIVES: I. Determine the toxicity and potential efficacy of high dose chemotherapy (HDC) comprised of etoposide, topotecan, and carboplatin (ETC) followed by autologous stem cell transplantation in patients with ovarian epithelial cancer. II. Determine the maximum tolerated dose of topotecan when combined with etoposide and carboplatin in these patients. III. Determine the disease free survival (DFS) and overall survival (OS) in patients treated with this regimen. IV. Measure the amount and subcellular location of DNA topoisomerase I and II- alpha in ovarian cancer biopsies before HDC and at relapse to determine the role of alterations of topoisomerases in the drug resistance of ovarian cancer. V. Correlate the amount and location of both enzymes before HDC with clinical outcome (DFS and OS) and plasma concentrations of topotecan and carboplatin in these patients. VI. Correlate the levels of signal transducers and activators of transcription (STAT) and expression of bcl-2 family proteins with response to chemotherapy and clinical outcome (DFS and OS) in these patients. VII. Measure the levels of STAT and determine the expression of bcl-2 family proteins in tumor biopsies before HDC and at relapse to determine the role of these cellular pathways in drug response. VIII. Determine the pharmacokinetic and pharmacodynamic relationship of high dose topotecan combined with carboplatin in these patients. PROTOCOL OUTLINE: This is a dose escalation study of topotecan. Mobilization: After completion of salvage chemotherapy and within 6 weeks of second look laparotomy, patients receive cyclophosphamide IV over 2 hours and paclitaxel IV over 2 hours for 2 days. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy and continuing until autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose chemotherapy: After priming chemotherapy and within 6 weeks of second look laparotomy, patients receive carboplatin IV over 1 hour on days -8 to -6; topotecan IV over 30 minutes on days -7 to -5 (beginning 12 hours after completion of carboplatin infusion); and etoposide IV over 4 hours on days -5 to -3 (beginning 12 hours after completion of the last topotecan infusion). Cohorts of 4-12 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 6 or more of 12 patients experience dose limiting toxicity. Transplantation: PBSC are reinfused on day 0. Patients are followed at 3 and 6 months, then annually thereafter. PROJECTED ACCRUAL: Approximately 4-30 patients will be accrued for this study within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IIIC ovarian epithelial cancer; Chemosensitive to 6-8 courses of standard dose adjuvant chemotherapy (one regimen), such as cisplatin or carboplatin in combination with paclitaxel, or any other standard dose regimen; Residual disease (no greater than 1 cm) following second look laparotomy; Ineligible if no microscopic disease present following induction chemotherapy OR Histologically proven newly diagnosed stage IV ovarian epithelial cancer; Achieved at least partial response (PR) (80% or greater reduction in tumor by CT scan) following six courses of standard dose chemotherapy (one regimen) OR Residual disease (no greater than 1 cm) or no disease determined at the time of second look laparotomy OR Histologically proven relapsed ovarian epithelial cancer; Relapse following standard dose chemotherapy; Chemosensitive; Achieved at least PR after 4-6 courses of salvage chemotherapy (total of 2 regimens) - No more than a six week interval between completion of standard dose chemotherapy and second look laparotomy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No prior topotecan - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics - Other: No concurrent nitroglycerin preparations or antiarrhythmic drugs --Patient Characteristics-- - Age: 18 to 65 - Performance status: ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT or AST no greater than 2.5 times normal - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: Ejection fraction at least 50% by MUGA scan; No severe cardiac dysfunction or major heart disease; No angina pectoris; No ventricular dysrhythmias; Essential hypertension allowed if controlled with medication(s) - Pulmonary: DLCO at least 50% predicted; No symptomatic obstructive or restrictive pulmonary disease - Other: No active infections; HIV negative; No uncontrolled insulin dependent diabetes mellitus; No uncompensated major thyroid or adrenal dysfunction; No other malignancy within the past 5 years except nonmelanomatous skin cancer; Not pregnant or nursing; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarenFields, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Additional Information:
Study ID Numbers: CDR0000067742; MCC-IRB-5418,MCC-12085,NCI-G00-1745
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005612
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
3. Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
4. Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
5. Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
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