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A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA


Phase 3
N/A
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA


OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the
progression-free interval and survival in patients with suboptimally resected stage III
ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity
of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality
of life (QOL) of these patients and determine whether secondary cytoreductive surgery
affects QOL.

OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or
objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination
Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875.
Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of
residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol;
CDDP.

PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400
evaluable patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage
III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following
exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient
The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma
Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed
epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant
Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of
ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade
0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for
this protocol are also eligible for protocol GOG-136

PATIENT CHARACTERISTICS: Age: Any age 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 more than 1.5 times normal ALT, AST, and GGT no more
than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3
times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of
congestive heart failure No myocardial infarction within 6 months No unstable angina
Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal
bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not
pregnant or nursing Effective contraception required of fertile patients

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 surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000063600

NCT ID:

NCT00002568

Start Date:

June 1994

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • Brenner tumor
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
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
Stanford University Medical Center Stanford, California  94305-5408
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
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
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 - Baptist Cancer Institute Memphis, Tennessee  38117
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Columbia River Program Portland, Oregon  97213
Lombardi Cancer Center, Georgetown University Washington, District of Columbia  20007
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195