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A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus


- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or
pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over
1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC
on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or
unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24

Inclusion Criteria


- Histologically confirmed uterine leiomyosarcoma

- Recurrent or persistent disease that is refractory to curative therapy or
established treatments

- Must have received 1 prior chemotherapy regimen that may include high-dose
therapy, consolidation, or extended therapy after surgical or nonsurgical

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Lesions within a previously irradiated field allowed provided progression is
documented or biopsy is obtained to confirm persistence at least 90 days
following completion of radiation therapy

- Ineligible for a high priority GOG protocol



- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.1 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN


- Creatinine no greater than 1.5 times ULN


- No active infection requiring antibiotics

- No motor or sensory neuropathy greater than grade 1

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

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

- At least 3 weeks since prior biologic or immunologic therapy for this disease


- See Disease Characteristics

- See Biologic therapy

- At least 3 weeks since prior chemotherapy and recovered

- No prior docetaxel or gemcitabine

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial regimens

- No prior chemotherapy for another malignancy that would preclude study

Endocrine therapy:

- At least 1 week since prior hormonal therapy for this disease

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- Recovered from prior recent surgery


- At least 3 weeks since other prior therapy for this disease

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

Martee L. Hensley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms
  • Sarcoma



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
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Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
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Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Avera Cancer Institute Sioux Falls, South Dakota  57105
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
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
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
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
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Aultman Hospital Cancer Center at Aultman Health Foundation Canton, Ohio  44710-1799
Banner Thunderbird Medical Center Phoenix, Arizona  85306
Fox Chase Virtua Health Cancer Program - Marlton Marlton, New Jersey  08053
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Mount Carmel West Hospital Columbus, Ohio  43222
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Yale Comprehensive Cancer Center at Yale University School of Medicine New Haven, Connecticut  06520-8064
University of Virginia Cancer Center Charlottesville, Virginia  22908
Elkhart General Hospital Elkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
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Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Parkland Memorial Hospital Dallas, Texas  75235
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees Camden, New Jersey  08103
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
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Colorado Gynecologic Oncology Group P.C. Aurora, Colorado  80010
Woman's Hospital Baton Rouge, Louisiana  70815
Methodist Cancer Center at Methodist Hospital - Omaha Omaha, Nebraska  68114
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Zale Lipshy University Hospital Dallas, Texas  75235-7786
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Rocky Mountain Gynecologic Oncology Englewood, Colorado  80110