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Ovarian CancerPhase 3NCT00003644

Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

A Phase 3 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by Gynecologic Oncology Group at 151 sites in 2 countries.

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 whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin… Read more about this study

Who is it for?
Ages Up to 120 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
571 participants
Where
151 sitesin 2 countries
Study dates
Oct 1998to Mar 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types:
  • Serous adenocarcinoma
  • Malignant Brenner's tumor
  • Mucinous adenocarcinoma
  • Endometrioid
  • Adenocarcinoma
  • Clear cell adenocarcinoma
  • Undifferentiated carcinoma
  • Transitional cell
  • Mixed epithelial carcinoma
  • Adenocarcinoma - not otherwise specified
  • Meets 1 of the following criteria:
  • Stage Ia or Ib, grade 3 or clear cell
  • Stage Ic or II, all grades/histologies
  • Complete surgical staging
  • No tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-3

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • SGOT no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • No major systemic medical illness expected to affect survival
  • Body surface area no greater than 2.0

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No prior treatment for this malignancy except surgical staging
  • No prior anticancer therapy that would preclude study participation

Trial locations and contacts

151 sites in 2 countries.

151 sites in 2 countries

United States144 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Tulane Cancer Center

    Alexandria, Louisiana, 71315-3198

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Colorado Gynecologic Oncology Group P.C.

    Aurora, Colorado, 80010

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Woman's Hospital

    Baton Rouge, Louisiana, 70815

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58502

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health - Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

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

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37901

  • Howard Community Hospital at Howard Regional Health System

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Todd Cancer Institute at Long Beach Memorial Medical Center

    Long Beach, California, 90801

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Baptist Centers for Cancer Care

    Memphis, Tennessee, 38120

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • University of Minnesota Medical Center & Children's Hospital - Fairview

    Minneapolis, Minnesota, 55455

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • OU Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

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

    Orange, California, 92868

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Joan Karnell Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University Cancer Institute

    Portland, Oregon, 97239-3098

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Bon Secours Cancer Institute at St. Mary's Hospital

    Richmond, Virginia, 23226

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia, 24014

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01199

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794-8174

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • Torrance Memorial Medical Center

    Torrance, California, 90509

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Japan7 sites

  • Kagoshima City Hospital

    Kagoshima City, Kagoshima, 892-8580

  • Kobe Medical Center

    Kobe, 654-0155

  • Shikoku Cancer Center

    Matsuyama, 790-0007

  • National Kyushu Cancer Center

    Minamiku, 811 1395

  • Tohoku University Graduate School of Medicine

    Sendai

  • National Cancer Center Hospital

    Tokyo, 104 0045

  • Tottori University Hospital

    Tottori, 680-8550

Other trials in Japan

About this study

Official title: A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma

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 whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Read the detailed description

OBJECTIVES:

  • Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
  • Assess the frequency and severity of toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.

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

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Conditions
Ovarian Cancer
Being tested
carboplatin, paclitaxel
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, Brenner tumor
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Brenner Tumor

What participants receive

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

Study groups in NCT00003644
Study groupRoleWhat they receive
Carboplatin, paclitaxel, low dose paclitaxelExperimentalcarboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
Receives: Drug: carboplatin; Drug: paclitaxel
Carboplatin, paclitaxelActive comparatorcarboplatin, paclitaxel
Receives: Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Progression-free Survival

    The percent of participants with disease recurrence within 5 years

    Measured: Up to 5 years

  2. Overall Survival

    Number of deaths during study and follow up.

    Measured: up to 96 months

  3. Number of Participants With Adverse Events Grade 3 or Greater

    Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants

    Measured: Throughout study treatment lasting up to 24 weeks

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 startOct 1998
  3. Primary completionMar 2010

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
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003644
Sponsor's protocol ID
GOG-0175
Other IDs
NCI-2012-02291, SWOG-G0175
Status last verified
Mar 2016
First submitted
1 Nov 1999
Last updated
4 Jun 2019
Data monitoring committee
Yes

Publications

  • Mannel RS, Brady MF, Kohn EC, Hanjani P, Hiura M, Lee R, Degeest K, Cohn DE, Monk BJ, Michael H. A randomized phase III trial of IV carboplatin and paclitaxel x 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2011 Jul;122(1):89-94. doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6.

    PubMed 21529904

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin and paclitaxel in people with Ovarian Cancer, run by Gynecologic Oncology Group at 151 sites in 2 countries.

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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Japan. 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?

Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (time frame: Up to 5 years). The study lists 3 primary outcomes in all. 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 NCT00003644, which also lists 1 linked publication.

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 4 Jun 2019.

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Clinical Trial NCT00003644 | AzTrials