Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	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	Biological: filgrastim Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cisplatin Paclitaxel Topotecan hydrochloride Filgrastim Topotecan Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Deborah K. Armstrong, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

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

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00002913 History of Changes
Other Study ID Numbers:	CDR0000065286, GOG-9602
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
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

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cisplatin
Paclitaxel
Topotecan
Lenograstim

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012