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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 - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Harrington Cancer CenterAmarillo, Texas  79106
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - NorthwestTacoma, Washington  98405-0986
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer CareMemphis, Tennessee  38120
Parkland Memorial HospitalDallas, Texas  75235
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Providence Centralia HospitalCentralia, Washington  98531-9027
Woman's HospitalBaton Rouge, Louisiana  70815
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Piedmont Hematology-Oncology AssociatesWinston-Salem, North Carolina  27103
Colorado Gynecologic Oncology Group, PCAurora, Colorado  80010
Hall and Martin, M.Ds., PCKnoxville, Tennessee  37920
Miami Cancer Center at Mercy HospitalMiami, Florida  33133