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A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy


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

Thank you

Trial Information

A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy


OBJECTIVES:

- Compare overall survival of patients with platinum-sensitive recurrent ovarian
epithelial or primary peritoneal cancer treated with carboplatin with or without
pegylated doxorubicin HCl liposome.

- Compare progression-free survival, confirmed complete response rates, and time to
treatment failure in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without
elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more),
and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl
liposome IV over 1 hour on day 1.

- Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats
every 4 weeks for a total of 15 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial carcinoma

- Stage III or IV disease at time of initial staging laparotomy

- Primary peritoneal and mixed Mullerian tumors allowed

- No borderline ovarian tumors

- Disease progression or recurrence after a progression-free and platinum-free interval
of 6-24 months after completion of first-line platinum-based chemotherapy (either
single agent or combination therapy)

- Disease progression or recurrence based solely on CA 125 elevation allowed, provided
that one of the following is true:

- Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no
greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal
(ULN) on 2 occasions at least 1 week apart

- Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA
125 greater than 2 times the nadir value on 2 occasions at least 1 week apart

- Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater
than 2 times ULN on 2 occasions at least 1 week apart

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

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

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

- Hemoglobin at least 10 g/dL

Hepatic

- SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- Bilirubin no greater than ULN

Renal

- Creatinine no greater than 1.9 mg/dL

Cardiovascular

- No New York Heart Association class II-IV cardiac disease

- No clinical evidence of congestive heart failure

- Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid
cancer

- No evidence of active or uncontrolled infection

- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or
gastrointestinal bleeding or diarrhea

- No greater than grade 1 preexisting sensory neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 28 days since prior biologic consolidation therapy

- No concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- At least 28 days since prior non-platinum-containing consolidation chemotherapy

- No prior pegylated doxorubicin HCl liposome

- No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose
in excess of 240 mg/m^2

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy

Radiotherapy

- No prior abdominopelvic irradiation

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- At least 28 days since prior surgical debulking for disease progression or recurrence
and recovered

- No concurrent surgery

Other

- No other prior treatment during the 6-24 month progression-free and platinum-free
interval except up to 12 courses of consolidation therapy

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Description:

From date of registration to date of death

Outcome Time Frame:

ten years

Safety Issue:

No

Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000256331

NCT ID:

NCT00043082

Start Date:

August 2002

Completion Date:

July 2011

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • peritoneal cavity cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
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 - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
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
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
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
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
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
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 - 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
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
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
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Loma Linda (Pettis)Loma Linda, California  92357
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Providence Cancer Institute at Providence Hospital - SouthfieldSouthfield, Michigan  48075
University of Tennessee Cancer Institute at Methodist Central HospitalMemphis, Tennessee  38104
California Cancer Center at Woodward Park OfficeFresno, California  93720