A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma
Carboplatin
+ Cyclophosphamide
+ Filgrastim
Urogenital Diseases+12
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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. 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 sub-cutaneously (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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Performance status - GOG 0 or 1 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal No active hepatitis Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No renal failure Curatively treated ureteral obstruction allowed if above creatinine measurements met 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) No significant nonneoplastic pulmonary disease 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 No prior chemotherapy for this malignancy No radiotherapy to greater than 25% of bone marrow See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location