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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 Optimally Debulked Stage III Ovarian Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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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 CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Chicago Cancer Research CenterChicago, Illinois  60637
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195