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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.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002913
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: cisplatin
Drug: filgrastim
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Filgrastim Cisplatin Paclitaxel Topotecan hydrochloride Topotecan Granulocyte colony-stimulating factor
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: December 1996
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002913

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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]
Armstrong DK, O'Reilly S, Bookman M, et al.: A phase I study of topotecan (T), cisplatin (C) and paclitaxel (P) in newly diagnosed epithelial ovarian cancer, a gynecologic oncology group (GOG 9602) study. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1351, 1998.

Study ID Numbers: CDR0000065286, GOG-9602
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002913  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Brenner tumor

Study placed in the following topic categories:
Cystadenocarcinoma, Serous
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Carcinoma, Endometrioid
Carcinoma
Genital Diseases, Female
Cisplatin
Paclitaxel
Endocrinopathy
Topotecan
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009