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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



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Evanston Evanston, Illinois  60201
Lombardi Cancer Center, Georgetown University Washington, District of Columbia  20007
St. Barnabas Medical Center Livingston, New Jersey  07039
North Shore University Hospital Manhasset, New York  11030
CCOP - Sooner State Tulsa, Oklahoma  74136
Medicine Branch Bethesda, Maryland  20892
Radiation Oncology Branch Bethesda, Maryland  20892