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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 Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Duluth Duluth, Minnesota  55805
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center Portland, Oregon  97201-3098
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Scripps Clinic Cancer Center La Jolla, California  92037