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A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma


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

Thank you

Trial Information

A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma


OBJECTIVES:

- Compare the progression-free interval and overall survival of patients with early stage
ovarian epithelial cancer treated with carboplatin and paclitaxel with or without
low-dose paclitaxel.

- Assess the frequency and severity of toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion
of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once
a week for 24 weeks.

- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo
observation.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial cancer of one of the following histologic
cell types:

- Serous adenocarcinoma

- Malignant Brenner's tumor

- Mucinous adenocarcinoma

- Endometrioid

- Adenocarcinoma

- Clear cell adenocarcinoma

- Undifferentiated carcinoma

- Transitional cell

- Mixed epithelial carcinoma

- Adenocarcinoma - not otherwise specified

- Meets 1 of the following criteria:

- Stage Ia or Ib, grade 3 or clear cell

- Stage Ic or II, all grades/histologies

- Complete surgical staging

- No tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-3

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- Alkaline phosphatase no greater than 3 times normal

- SGOT no greater than 3 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No major systemic medical illness expected to affect survival

- Body surface area no greater than 2.0

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- No prior treatment for this malignancy except surgical staging

- No prior anticancer therapy that would preclude study participation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free interval

Safety Issue:

No

Principal Investigator

Robert S. Mannel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Oklahoma College of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000066732

NCT ID:

NCT00003644

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II 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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Memorial Hospital of South BendSouth Bend, Indiana  46601
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Gynecologic Oncology NetworkGreenville, North Carolina  27858
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
University of California Davis Cancer CenterSacramento, California  95817
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Torrance Memorial Medical CenterTorrance, California  90505
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Southwest Medical CenterLiberal, Kansas  67901
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer CareMemphis, Tennessee  38120
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
California Pacific Medical Center - California CampusSan Francisco, California  94118
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Baptist Regional Cancer Center at Baptist Hospital of East TennesseeKnoxville, Tennessee  37901
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Tulane Cancer CenterNew Orleans, Louisiana  70112
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Highlands Oncology Group - FayettevilleFayetteville, Arkansas  72703
Washington Regional Medical CenterFayetteville, Arkansas  72703
Colorado Gynecologic Oncology Group P.C.Aurora, Colorado  80010
Cancer Resource Center at King's Daughters Medical CenterAshland, Kentucky  41101
Woman's HospitalBaton Rouge, Louisiana  70815
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Mid Dakota Clinic, PCBismarck, North Dakota  58501
OU Cancer InstituteOklahoma City, Oklahoma  73104
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Bon Secours Cancer Institute at St. Mary's HospitalRichmond, Virginia  23226