AzTrials
AzTrials

Ovarian CancerPhase 3NCT00043082

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

A Phase 3 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by SWOG Cancer Research Network at 91 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Ovarian Cancer, Peritoneal Cavity Cancer
What is being tested?
carboplatin and pegylated liposomal doxorubicin hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
91 sitesUnited States
Study dates
Aug 2002to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

United States91 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0948

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428-1002

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • California Cancer Center at Woodward Park Office

    Fresno, California, 93720

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4095

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7353

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Loma Linda (Pettis)

    Loma Linda, California, 92357

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute at Methodist Central Hospital

    Memphis, Tennessee, 38104

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36607

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Providence Cancer Institute at Providence Hospital - Southfield

    Southfield, Michigan, 48075

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
carboplatin, pegylated liposomal doxorubicin hydrochloride
Keywords
peritoneal cavity cancer, recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    intravenous q 4 weeks

  • pegylated liposomal doxorubicin hydrochlorideDrug

    intravenous q 4 weeks

Study groups in NCT00043082
Study groupRoleWhat they receive
carboplatin and doxorubicinExperimentalcarboplatin and liposomal doxorubicin given q 4 weeks
Receives: Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride
carboplatinActive comparatorcarboplatin alone
Receives: Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    From date of registration to date of death

    Measured: ten years

Secondary outcomes (2)

  1. progression free survival and response

    response by RECIST criteria

    Measured: 10 years

  2. side effects

    side effects described per NCI CTC version 2.0

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJun 2007
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00043082
Sponsor's protocol ID
CDR0000256331
Other IDs
S0200, U10CA032102
Status last verified
Oct 2015
First submitted
5 Aug 2002
Last updated
26 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Alberts DS, Liu PY, Wilczynski SP, Clouser MC, Lopez AM, Michelin DP, Lanzotti VJ, Markman M; Southwest Oncology Group. Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200). Gynecol Oncol. 2008 Jan;108(1):90-4. doi: 10.1016/j.ygyno.2007.08.075. Epub 2007 Oct 18.

    PubMed 17949799

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by SWOG Cancer Research Network at 91 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: ten years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00043082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in