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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
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

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


OBJECTIVES:

- 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
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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
assessment

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

- 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

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

- 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

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- Recovered from prior recent surgery

Other:

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

- No concurrent amifostine or other protective agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

Martee L. Hensley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069206

NCT ID:

NCT00031629

Start Date:

January 2002

Completion Date:

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Avera Cancer InstituteSioux Falls, South Dakota  57105
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
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
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Mount Carmel West HospitalColumbus, Ohio  43222
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Parkland Memorial HospitalDallas, Texas  75235
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Geisinger Medical GroupState College, Pennsylvania  16801
Colorado Gynecologic Oncology Group P.C.Aurora, Colorado  80010
Woman's HospitalBaton Rouge, Louisiana  70815
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Zale Lipshy University HospitalDallas, Texas  75235-7786
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Rocky Mountain Gynecologic OncologyEnglewood, Colorado  80110