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Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma

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: NCT00227669
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.

PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: docetaxel Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • Compare the anti-tumor activity, in terms of objective response rate, in patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with gemcitabine with vs without docetaxel as second-line therapy.


  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the response duration and overall survival of patients treated with these regimens.
  • Compare the tolerability and dose intensity of these regimens in these patients.
  • Determine biological markers with a predictive value for response to these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to location of leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4 weeks for 2-8 courses.
  • Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment repeats every 3 weeks for 2-8 courses.

PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas
Study Start Date : October 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Active Comparator: Arm I: Gemcitabine

Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22.

1 cycle = 28 days.

Treatment duration: 8 months

Drug: gemcitabine hydrochloride
Experimental: Arm II: Gemcitabine + Docetaxel

Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8.

1 cycle = 21 days.

Treatment duration: 6 months

Drug: docetaxel
Drug: gemcitabine hydrochloride

Primary Outcome Measures :
  1. Anti-tumoral activity (objective response rate) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
  2. Response duration [ Time Frame: 3 years ]
  3. Tolerability [ Time Frame: 3 years ]
  4. Dose intensity [ Time Frame: 3 years ]
  5. Overall survival [ Time Frame: 3 years ]
  6. Biological markers [ Time Frame: 3 years ]

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 to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the following criteria:

    • Metastatic disease
    • Relapsed and unresectable disease
  • Prior treatment with a first-line anthracycline-based chemotherapy regimen required

    • Relapsed disease > 1 year after adjuvant chemotherapy is considered untreated disease
    • If relapsed disease occurs < 1 year after adjuvant therapy, then adjuvant therapy is considered a first-line treatment
  • At least 1 measurable lesion, defined as the following:

    • At least 1 target lesion must be located in a non-irradiated area
    • Obvious disease progression within the past 6 weeks
  • No other uterine sarcomas, including any of the following:

    • Carcinosarcoma
    • Endometrial stroma sarcoma
    • Other soft tissue sarcoma
  • No symptomatic or known brain metastases



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No specific hepatic contraindication to study treatment
  • Hepatitis B core and hepatitis B surface antigen negative


  • Creatinine < 1.5 times ULN
  • No specific renal contraindication to study treatment


  • No specific cardiac contraindication to study treatment


  • HIV negative
  • No specific allergic contraindication to study treatment
  • No active infection


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other serious underlying pathology that would preclude study treatment
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No neurotoxicity > grade 2
  • No psychological, sociological, or geographical condition that would preclude study compliance or follow-up schedule
  • No prior or concurrent psychiatric illness


Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No prior allogeneic graft or autologous graft


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No prior gemcitabine and/or taxane (i.e., docetaxel or paclitaxel)

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the only evaluable lesion


  • Not specified


  • No concurrent participation in another clinical trial using an experimental agent

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): NCT00227669

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Sponsors and Collaborators
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Study Chair: Florence Duffaud, MD CHU de la Timone
Publications of Results:
Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

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Responsible Party: UNICANCER Identifier: NCT00227669    
Other Study ID Numbers: CDR0000443572
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared at an individual level.
Keywords provided by UNICANCER:
uterine leiomyosarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
adult leiomyosarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
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