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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



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