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A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma


OBJECTIVES: I. Compare progression free and overall survival and frequency of response in
patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal
cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin.
II. Determine the incidence and severity of adverse events, including catheter complications
and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between
plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient
population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and measurable disease (yes vs no). Patients are randomized into one of
two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours
followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously
over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6
courses.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or
primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with
maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no
greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following
histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous
adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell
adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not
otherwise specified Measurable disease not required Cytologic confirmation of malignant
pleural effusion required if sole basis of entry No borderline (low malignant potential)
carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but
unexplored or unable to verify tumor arising from ovarian stroma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC
at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no
greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no
greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL
Cardiovascular: No history of congestive heart failure No history of unstable angina No
myocardial infarction within 6 months Other: No severe infection, including septicemia No
severe gastrointestinal bleeding No history of second malignancy within 5 years except
nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics No more than 6 weeks since staging laparotomy and primary
cytoreductive surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064554

NCT ID:

NCT00002717

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • 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
  • primary peritoneal cavity cancer
  • Brenner tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Central IllinoisSpringfield, Illinois  62526