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Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
This study has been completed.
Study NCT00002913   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
December 1996
July 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00002913 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer.

OBJECTIVES:

  • Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer.
  • Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF.
  • Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients.

OUTLINE: This is a dose escalation study of topotecan.

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed as clinically indicated.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

Phase I
Interventional
Treatment
Ovarian Cancer
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: paclitaxel
  • Drug: topotecan hydrochloride
 
Armstrong DK, Bookman MA, McGuire W, Bristow RE, Schilder JM. A phase I study of paclitaxel, topotecan, cisplatin and Filgrastim in patients with newly diagnosed advanced ovarian epithelial malignancies: A Gynecologic Oncology Group study. Gynecol Oncol. 2007 Mar 16; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
 
July 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed epithelial ovarian carcinoma

    • No borderline ovarian carcinoma
    • Stage III/IV disease that has been suboptimally or optimally debulked
  • The following histologies are eligible:

    • Adenocarcinoma (unspecified)
    • Mucinous cystadenocarcinoma
    • Clear cell adenocarcinoma
    • Serous cystadenocarcinoma
    • Endometrioid adenocarcinoma
    • Transitional cell carcinoma
    • Malignant Brenner's tumor
    • Undifferentiated carcinoma
    • Mixed epithelial carcinoma
    • Extraovarian papillary serous cystadenocarcinoma
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-1

Life expectancy:

  • Enabling completion of at least 2 courses of therapy

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

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No myocardial infarction within 6 months
  • No congestive heart failure
  • No unstable or uncontrolled angina
  • No history of cardiac arrhythmia requiring anti-arrhythmia medication
  • No uncontrolled hypertension

Other:

  • No hypersensitivity to E. coli-derived drug preparation
  • No active infection
  • No sensory neuropathy
  • No other malignancies within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Recovered from any recent surgery
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002913
 
CDR0000065286, GOG-9602
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2002

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