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A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


Phase 2
N/A
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


OBJECTIVES:

- Determine the antitumor activity of gemcitabine and docetaxel in patients with
recurrent or persistent 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 gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days
1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or
disease progression.

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

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed uterine carcinosarcoma

- Malignant mixed Müllerian tumor, homologous or heterologous type

- Recurrent or persistent disease

- Progressive disease after prior local therapy

- 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
except documented progression or biopsy to confirm persistence at least 90 days
after completion of radiation therapy

- Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma

- Initial treatment may have included high-dose therapy, consolidation, or
extended therapy administered after surgical or non-surgical assessment

- Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol
for the same patient population)

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Pulmonary

- No severe pulmonary disease requiring oxygen supplementation

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 neuropathy (sensory or motor) > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy

- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal
antibodies, cytokines, or small molecule inhibitors of signal transduction) for
recurrent or persistent disease

Chemotherapy

- See Disease Characteristics

- See Biologic therapy

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or
combination therapy

- No prior docetaxel or gemcitabine

Endocrine therapy

- At least 1 week since prior hormonal therapy for the malignancy

- Concurrent hormone replacement therapy allowed

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery

- Recovered from prior surgery

Other

- At least 3 weeks since other prior therapy for the malignancy

- No prior cancer treatment that would preclude study therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:

No

Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000434843

NCT ID:

NCT00114218

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Sarcoma
  • uterine carcinosarcoma
  • recurrent uterine sarcoma
  • Carcinosarcoma
  • Sarcoma

Name

Location

Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Avera Cancer Institute Sioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Harrington Cancer Center Amarillo, Texas  79106
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
CCOP - Northwest Tacoma, Washington  98405-0986
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
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
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
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
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
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
University of Virginia Cancer Center Charlottesville, Virginia  22908
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Hope A Women's Cancer Center Asheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
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
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer Care Memphis, Tennessee  38120
Parkland Memorial Hospital Dallas, Texas  75235
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Providence Centralia Hospital Centralia, Washington  98531-9027
Woman's Hospital Baton Rouge, Louisiana  70815
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Piedmont Hematology-Oncology Associates Winston-Salem, North Carolina  27103
Colorado Gynecologic Oncology Group, PC Aurora, Colorado  80010
Hall and Martin, M.Ds., PC Knoxville, Tennessee  37920
Miami Cancer Center at Mercy Hospital Miami, Florida  33133