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SarcomaPhase 2NCT00112489

Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer

A Phase 2 study testing carboplatin and paclitaxel in people with Sarcoma, run by Gynecologic Oncology Group at 110 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, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Sarcoma
What is being tested?
carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
110 sitesin 2 countries
Study dates
May 2005to Jul 2010
Phase
Phase 2
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 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)
  • Stage III or IV disease
  • Persistent or recurrent disease
  • Documented disease progression
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • At least 1 target lesion
  • Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression
  • Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No sensory or motor neuropathy > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy for uterine sarcoma

Endocrine therapy

  • At least 1 week since prior hormonal therapy for uterine sarcoma
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • No prior anticancer therapy that would preclude study therapy

Trial locations and contacts

110 sites in 2 countries.

110 sites in 2 countries

United States99 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28801

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Woman's Hospital

    Baton Rouge, Louisiana, 70815

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • 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

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

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

    Dallas, Texas, 75390

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Holland Community Hospital

    Holland, Michigan, 49423

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • 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

  • Hall and Martin, M.Ds., PC

    Knoxville, Tennessee, 37920

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Jersey Shore Cancer Center at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754-0397

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19140

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Black Hills Obstetrics & Gynecology LLP

    Rapid City, South Dakota, 57701

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia, 24014

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

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

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • 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 St. Peters Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Saint Mary's Health Center

    St Louis, Missouri, 63117

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Cancer Care Associates - Midtown Tulsa

    Tulsa, Oklahoma, 74104

  • 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

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Piedmont Hematology-Oncology Associates

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

Japan11 sites

  • Kagoshima City Hospital

    Kagoshima City, Kagoshima, 892-8580

  • Kobe Medical Center

    Kobe, 654-0155

  • National Hospital Organization - Medical Center of Kure

    Kure, 737

  • Shikoku Cancer Center

    Matsuyama, 791-0288

  • National Kyushu Cancer Center

    Minamiku, 811 1395

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Kinki University School of Medicine

    Osaka, Osaka, 589 8511

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Graduate School of Medicine

    Sendai

  • Keio University School of Medicine

    Shinjuku-ku, 160-8582

  • Tottori University Hospital

    Tottori, 680-8550

Other trials in Japan

About this study

Official title: A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Conditions
Sarcoma
Being tested
carboplatin, paclitaxel
Keywords
recurrent uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, uterine carcinosarcoma
Medical subject headings
Sarcoma

What participants receive

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

Study groups in NCT00112489
Study groupRoleWhat they receive
Taxol-CarboExperimentalPaclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
Receives: Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Nature and Degree of Toxicity

    Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0

    Measured: During study treatment and up to 30 days after stopping study treatment

  2. Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response

    Primary outcome measured according to RECIST v1.0 Best Response:

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

    Measured: Response was measured every other cycle (q 6 weeks) until disease progression is documented.

Timeline

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

  1. First posted3 Jun 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionJul 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112489
Sponsor's protocol ID
CDR0000432956
Other IDs
GOG-0232B
Status last verified
Apr 2014
First submitted
2 Jun 2005
Last updated
25 Sep 2018
Data monitoring committee
Yes

Publications

  • Powell MA, Filiaci VL, Rose PG, Mannel RS, Hanjani P, Degeest K, Miller BE, Susumu N, Ueland FR. Phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. J Clin Oncol. 2010 Jun 1;28(16):2727-31. doi: 10.1200/JCO.2009.26.8326. Epub 2010 Apr 26.

    PubMed 20421537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin and paclitaxel in people with Sarcoma, run by Gynecologic Oncology Group at 110 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 12 May 2014). 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?

Nature and Degree of Toxicity (time frame: During study treatment and up to 30 days after stopping study treatment). The study lists 2 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 NCT00112489, 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 25 Sep 2018.

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