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A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma


Phase 3
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma


OBJECTIVES:

- Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine,
doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free
survival, in patients with stage III or IV ovarian epithelial or serous primary
peritoneal carcinoma.

- Determine the response rate in patients with measurable disease treated with these
regimens.

- Compare the toxic effects of these regimens in these patients.

- Compare the complications in patients treated with these regimens.

- Determine the dose-intensity and cumulative dose delivery for these regimens in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata
according to extent of residual disease and plans for interval cytoreductive surgery:

- Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for
surgery

- Stratum B: Suboptimal residual disease without plans for surgery

- Stratum C: Suboptimal residual disease with plans for surgery Patients are randomized
to 1 of 5 treatment arms.

- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on
days 1 and 8. Treatment continues as in arm I.

- Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin
HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues
as in arm I.

- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV
over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients
then receive 4 courses of arm I chemotherapy.

- Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin
IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients
then receive 4 courses of arm I chemotherapy.

Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may
undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.

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

PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be
accrued for this study within 3.5-5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV ovarian epithelial or serous primary
peritoneal carcinoma

- The following are ineligible:

- Germ cell tumors

- Sex cord-stromal tumors

- Carcinosarcomas

- Mixed Mullerian tumors or carcinosarcomas

- Metastatic carcinomas from other sites to the ovary

- Low malignant potential tumors, including micropapillary serous carcinomas

- Mucinous primary peritoneal carcinoma

- Prior ovarian low malignant potential tumor (borderline carcinoma) that was
surgically resected with subsequent development of invasive adenocarcinoma allowed if
no prior chemotherapy

- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery

- Prior breast cancer allowed provided the following are true:

- Disease-free for more than 5 years

- No prior cytotoxic chemotherapy for breast cancer

- Prior or concurrent primary endometrial cancer allowed if the following conditions
are met:

- Stage no greater than IB

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- No acute hepatitis

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No unstable angina

- No myocardial infarction within the past 6 months

- No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block)
unless stable for the past 6 months

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No greater than grade 1 sensory or motor neuropathy

- No active infection that requires antibiotics

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

- No severe or ongoing gastrointestinal bleeding that requires blood product support

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed
provided the following are true:

- More than 3 years since prior therapy

- No evidence of recurrent disease

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- Prior radiotherapy for localized breast, head and neck, or skin cancer allowed
provided the following are true:

- More than 3 years since prior therapy

- No evidence of recurrent disease

Surgery:

- See Disease Characteristics

- No more than 12 weeks since prior surgical resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael A. Bookman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068467

NCT ID:

NCT00011986

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
MBCCOP - Hawaii Honolulu, Hawaii  96813
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Ireland Cancer Center Cleveland, Ohio  44106-5065
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Wichita Wichita, Kansas  67214-3882
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Huntsman Cancer Institute Salt Lake City, Utah  84112
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
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
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 - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Evanston Evanston, Illinois  60201
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
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
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - Houston Houston, Texas  77030
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 - New Orleans New Orleans, Louisiana  70112
Providence Alaska Medical Center Anchorage, Alaska  99508
University of California Davis Cancer Center Sacramento, California  95817
City of Hope Comprehensive Cancer Center Duarte, California  91010
Cooper University Hospital Camden, New Jersey  08103
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Veterans Affairs Medical Center - Amarillo Amarillo, Texas  79106
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
St. Louis University Hospital Cancer Center Saint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Veterans Affairs Medical Center - Salisbury Salisbury, North Carolina  28144
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Tufts - New England Medical Center Boston, Massachusetts  02111
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Cancer Center at Lexington Clinic Lexington, Kentucky  40504
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Arthur G. James Cancer Hospital at Ohio State University Columbus, Ohio  43210-1240
Gynecologic Oncology Network Nashville, Tennessee  37203
Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Providence Cancer Institute at Providence Hospital Southfield, Michigan  48075
Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital) Hines, Illinois  60141