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A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

Phase 3
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in
patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma
receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal
(IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these
2 treatment regimens in these patients. III. Determine the frequency and prognostic
significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of
non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer
or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving
these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to gross residual
disease (present vs absent) and whether second-look surgery will be performed at the end of
treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before
the start of chemotherapy, but after randomization. Patients are randomized to one of two
treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1
followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour
infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on
day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses.
Following chemotherapy, second look surgery is performed if selected by the patient.
Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6
weeks after the completion of course 6 and prior to second look surgery if selected, 6
months after treatment is completed, and 12 months after treatment is completed. Patients
are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven primary peritoneal carcinoma or optimal (no
greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the
following epithelial cell types: Serous adenocarcinoma Endometrioid adenocarcinoma
Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed
epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Adenocarcinoma
NOS Prior surgery for ovarian/peritoneal carcinoma required No epithelial ovarian
carcinoma of low malignant potential (borderline carcinoma)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine
no greater than 2.0 mg/dL Cardiovascular: No unstable angina No myocardial infarction
within prior 6 months Patients with abnormal cardiac conduction are eligible if disease
stable for at least 6 months Other: No septicemia or severe infection No severe
gastrointestinal bleeding No other invasive malignancy within past 5 years except
nonmelanoma skin cancer Any previous cancer treatment must not contraindicate this
protocol therapy

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Deborah K. Armstrong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • recurrent 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
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



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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
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
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
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
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - EvanstonEvanston, Illinois  60201
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
St. Barnabas Medical CenterLivingston, New Jersey  07039
North Shore University HospitalManhasset, New York  11030
CCOP - Sooner StateTulsa, Oklahoma  74136
Medicine BranchBethesda, Maryland  20892
Radiation Oncology BranchBethesda, Maryland  20892