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A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus


Phase 2
18 Years
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus


OBJECTIVES:

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

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

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic
radiotherapy (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour
on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR
pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed uterine leiomyosarcoma

- Advanced, persistent, or recurrent disease

- Documented disease progression

- Measurable disease

- At least 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 considered nontarget lesions

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

PATIENT CHARACTERISTICS:

Age

- Adult

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 of normal (ULN)

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy (sensory or motor) > grade 1

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

- No active infection requiring antibiotics

- No known hypersensitivity to E. coli-derived proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior cytotoxic chemotherapy for the malignancy

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

- Recovered from all other prior therapy

- No prior cancer treatment that would preclude study treatment

- 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:

CDR0000405892

NCT ID:

NCT00101127

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • uterine leiomyosarcoma
  • Leiomyosarcoma
  • Sarcoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphia, Pennsylvania  19102
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Rapid City Regional HospitalRapid City, South Dakota  57709
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
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
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Medical Center of Central GeorgiaMacon, Georgia  31201
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
UMDNJ University HospitalNewark, New Jersey  07103
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
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
New Britain General HospitalNew Britain, Connecticut  06050
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
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
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Baptist Centers for Cancer CareMemphis, Tennessee  38120
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Woman's HospitalBaton Rouge, Louisiana  70815
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208