S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer

October 23, 2015 updated by: Southwest Oncology Group

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without liposomal doxorubicin in treating recurrent ovarian epithelial or primary peritoneal cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, United States, 93720
        • California Cancer Center at Woodward Park Office
      • Loma Linda, California, United States, 92357
        • Veterans Affairs Medical Center - Loma Linda (Pettis)
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60612
        • MBCCOP - University of Illinois at Chicago
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines
      • Maywood, Illinois, United States, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7353
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, United States, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, United States, 48109-0948
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Hospital Cancer Center
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Dayton, Ohio, United States, 45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute at Methodist Central Hospital
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98109
        • Puget Sound Oncology Consortium
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carboplatin and doxorubicin
carboplatin and liposomal doxorubicin given q 4 weeks
Drug: carboplatin
intravenous q 4 weeks
Drug: pegylated liposomal doxorubicin hydrochloride
intravenous q 4 weeks
Active Comparator: carboplatin
carboplatin alone
Drug: carboplatin
intravenous q 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: ten years
From date of registration to date of death
ten years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival and response
Time Frame: 10 years
response by RECIST criteria
10 years
side effects
Time Frame: 15 months
side effects described per NCI CTC version 2.0
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David S. Alberts, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000256331
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0200 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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