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.

Condition	Treatment or Intervention	Phase
ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma peritoneal cavity cancer ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma stage III ovarian epithelial cancer ovarian clear cell cystadenocarcinoma stage IV ovarian epithelial cancer Brenner Tumor	Drug: carboplatin  Drug: paclitaxel  Drug: topotecan	Phase I

Further Study Details: 

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 topetecan administration in these patients.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
California
      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Tampa Bay Cancer Consortium, Saint Petersburg,  Florida,  33701,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Maryland
      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States
Massachusetts
      Tufts University School of Medicine, Boston,  Massachusetts,  02111,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Ellis Fischel Cancer Center, Columbia,  Missouri,  65203,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States
New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-7775,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Study chairs or principal investigators

Michael A. Bookman,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000067547; GOG-9906
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005026
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08