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 with previously untreated stage III or stage IV ovarian or primary peritoneal cancer.

Condition	Treatment or Intervention	Phase
peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer	Drug: carboplatin  Drug: gemcitabine  Drug: paclitaxel	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma.

II. Determine the response rate (in patients with measurable disease) and progression-free interval in these patients receiving this treatment.

PROTOCOL OUTLINE: This is a feasibility study.

On day 1, patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every 21 days for a maximum of 8 courses.

Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within approximately 2 years.

Ages Eligible for Study:  18 Years   -   80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed, previously untreated: Stage III or stage IV ovarian epithelial cancer; Stage III or stage IV primary peritoneal cancer

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for this or any other malignancy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy for this or any other malignancy
• Surgery: No prior surgery other than cytoreductive surgery and recovered

--Patient Characteristics--

• Age: 18 to 80
• Performance status: GOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 3 times ULN; Alkaline phosphatase no greater than 3 times ULN
• Renal: Creatinine no greater than 1.5 mg/dL
• Other: Effective contraception required of fertile patients; No significant infections; No other severe medical problems that would subject patient to undue risk from this protocol; No other active malignancy within past 5 years except nonmelanomatous skin cancer

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States
California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Women's Cancer Center, Palo Alto,  California,  94304,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      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,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Central Illinois, Springfield,  Illinois,  62526,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
      Medicine Branch, Bethesda,  Maryland,  20892,  United States
      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States
Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  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,  11790-9832,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Brookview Research, Inc., Winston Salem,  North Carolina,  27103,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, 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,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  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,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Canada, Ontario
      NCIC-Clinical Trials Group, Kingston,  Ontario,  K7L 3N6,  Canada

Study chairs or principal investigators

Katherine Yvonne Look,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000066372; GOG-9801
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08