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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
This study is ongoing, but not recruiting participants.
Study NCT00004221   Information provided by National Cancer Institute (NCI)
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes

January 28, 2000
February 6, 2009
November 1999
 
 
 
Complete list of historical versions of study NCT00004221 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
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

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 and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer.

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.

Phase II
Interventional
Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: paclitaxel
  • Drug: topotecan hydrochloride
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004221
 
CDR0000067462, GOG-9903
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP