Know Cancer

or
forgot password

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 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
Stanford University Medical CenterStanford, California  94305-5408
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
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
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 - Baptist Cancer InstituteMemphis, Tennessee  38117
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Columbia River ProgramPortland, Oregon  97213
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195