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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 CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
MBCCOP - HawaiiHonolulu, Hawaii  96813
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Ireland Cancer CenterCleveland, Ohio  44106-5065
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tacoma General HospitalTacoma, Washington  98405
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
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
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
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 - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
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
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
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 - New OrleansNew Orleans, Louisiana  70112
Providence Alaska Medical CenterAnchorage, Alaska  99508
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Cooper University HospitalCamden, New Jersey  08103
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
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
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Veterans Affairs Medical Center - SalisburySalisbury, North Carolina  28144
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Tufts - New England Medical CenterBoston, Massachusetts  02111
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Cancer Center at Lexington ClinicLexington, Kentucky  40504
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
Gynecologic Oncology NetworkNashville, Tennessee  37203
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075
Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)Hines, Illinois  60141