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Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy


OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on
progression free survival and overall survival in women with advanced ovarian, fallopian
tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin
or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated
with prolonged paclitaxel administration in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs
suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours
vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to
one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 12 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months until disease progression or 1
year from registration, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study
within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian
tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy
with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial
laparotomy Must have attained a clinically defined complete remission (CR) following
treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination
chemotherapy regimen by achieving the following: No evidence of cancer on physical
examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative
ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or
chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy
Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to
study Must register for study within 21 to 56 days after prior chemotherapy Not
concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line
treatment phase III GOG trials

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least
100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other:
No prior malignancy within past 5 years except adequately treated basal cell or squamous
cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No
concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior
chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin
allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent
chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent
radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No
second look laparotomy or laparoscopy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

duration between date of enrollment and date first recurrence or death due to any cause.

Safety Issue:

No

Principal Investigator

Maurie Markman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065875

NCT ID:

NCT00003120

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer CenterPortland, Oregon  97201-3098
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Scripps Clinic Cancer CenterLa Jolla, California  92037