Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

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


- 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

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

Inclusion Criteria


- 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)



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- 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


Biologic therapy

- Not specified


- 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


- See Disease Characteristics


- Not specified


- Recovered from all prior therapy

- No prior anticancer therapy that would preclude study therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

Matthew A. Powell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • uterine carcinosarcoma
  • Carcinosarcoma
  • Sarcoma



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hurley Medical Center Flint, Michigan  48503
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Avera Cancer Institute Sioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Froedtert Hospital and Medical College of Wisconsin Milwaukee, Wisconsin  53226-3596
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
SUNY Downstate Medical Center Brooklyn, New York  11203
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Mount Sinai Medical Center New York, New York  10029
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Hope A Women's Cancer Center Asheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Parkland Memorial Hospital Dallas, Texas  75235
Mecosta County Medical Center Big Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Woman's Hospital Baton Rouge, Louisiana  70815
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
St. Vincent's Medical Center Jacksonville, Florida  32203
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Piedmont Hematology-Oncology Associates Winston-Salem, North Carolina  27103
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis St Louis, Missouri  63110
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Black Hills Obstetrics & Gynecology LLP Rapid City, South Dakota  57701
Hall and Martin, M.Ds., PC Knoxville, Tennessee  37920
Saint Mary's Health Center St. Louis, Missouri  63117