Brief Title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
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 Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Brief Summary
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.
Detailed Description
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
filgrastim
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3
Start Date
August 1998
Completion Date
February 2003
Primary Completion Date
December 1999
Eligibility 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
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
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Russell J. Schilder, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003944
Organization ID
CDR0000067137
Secondary IDs
FCCC-98030
Responsible Party
Sponsor
Study Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Russell J. Schilder, MD, Study Chair, Fox Chase Cancer Center
Verification Date
April 2013