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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
This study has been completed.
Study NCT00005026   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes

April 6, 2000
July 23, 2008
February 2000
January 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00005026 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel (Sequential Doublets) in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.

OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these patients with this treatment regimen. III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topotecan administration in these patients.

OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen III: Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.

Phase I
Interventional
Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: topotecan hydrochloride
 
Bookman MA, McMeekin DS, Fracasso PM. Sequence dependence of hematologic toxicity using carboplatin and topotecan for primary therapy of advanced epithelial ovarian cancer: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):473-8. Epub 2006 May 2.

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

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal carcinoma Prior surgery required within the past 12 weeks Either optimal (no greater than 1 cm residual disease) or suboptimal residual disease following initial surgery No ovarian epithelial tumors of low malignant potential (borderline tumor) The following histologic epithelial cell types are eligible: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 2.5 times ULN No acute hepatitis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for past 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No concurrent or prior invasive malignancies within past 5 years except nonmelanoma skin cancer No greater than grade 1 neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No prior cancer treatment that contraindicates study protocol

Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00005026
 
CDR0000067547, GOG-9906
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Michael A. Bookman, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
July 2008

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