Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004066
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

December 10, 1999
January 27, 2003
March 7, 2013
June 1999
October 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004066 on Archive Site
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Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.


  • Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma.
  • Determine the tolerability of this regimen in these patients.
  • Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients.

OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy.

Patients are followed every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.

Phase 2
Primary Purpose: Treatment
  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • Biological: filgrastim
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
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Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
October 2003
October 2003   (Final data collection date for primary outcome measure)


  • Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma

    • No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas
  • Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy
  • No prior chemotherapy OR
  • Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma
  • Bidimensionally measurable disease by physical examination or medical imaging techniques

    • Ascites and pleural effusions are not considered measurable disease
  • No uncontrolled CNS metastases



  • 18 and over

Performance status:

  • Karnofsky 60-100%

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 1.5 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • No active or uncontrolled infection
  • No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix
  • No history of grade 3 or 4 peripheral neuropathy
  • Not pregnant or nursing


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior gemcitabine or docetaxel

Endocrine therapy:

  • Not specified


  • At least 6 weeks since prior radiotherapy


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA008748 ( U.S. NIH Grant/Contract )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert Maki, MD, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP