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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

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

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 Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

February 2003

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111