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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Sarcoma Small Intestine Cancer Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma
Study Start Date : June 1999
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004066

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Robert Maki, MD, PhD Memorial Sloan Kettering Cancer Center

Publications of Results:
Layout table for additonal information Identifier: NCT00004066    
Other Study ID Numbers: 99-027
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
adult leiomyosarcoma
recurrent adult soft tissue sarcoma
small intestine leiomyosarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma
ovarian sarcoma
recurrent small intestine cancer
stage IV adult soft tissue sarcoma
Additional relevant MeSH terms:
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Intestinal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Muscle Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic