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 Carcinoma
18 Years
N/A
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
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 Carcinoma
OBJECTIVES:
- 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.
- 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 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.
Inclusion 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
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- GOG 0 or 1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Russell J. Schilder, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067462
NCT ID:
NCT00004221
Start Date:
November 1999
Completion Date:
Related Keywords:
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage III ovarian epithelial cancer
- ovarian undifferentiated adenocarcinoma
- ovarian mixed epithelial carcinoma
- ovarian serous cystadenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
