Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

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: NCT00807261
Recruitment Status : Unknown
Verified December 2008 by Asan Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : December 11, 2008
Last Update Posted : December 12, 2008
Severance Hospital
Korea University Anam Hospital
Samsung Medical Center
Information provided by:
Asan Medical Center

Brief Summary:

To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

  1. Primary endpoint: response rate
  2. Secondary endpoint: progress-free survival, overall survival, safety

Condition or disease Intervention/treatment Phase
Sarcoma Drug: Gemcitabine and Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Intervention Details:
    Drug: Gemcitabine and Docetaxel

    Drug and schedule

    • Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8)
    • Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days

    Dose modification

    • Treatment should be delayed if the ANC<1,500/ mm3, or if the platelet count <75,000/mm3 on the first day of the next cycle.
    • Gemcitabine & docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy.

    Patients with response or no change will receive 2 additional cycles.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors)
  • Bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver)
  • Patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy Patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment
  • unidimensional measurable lesions
  • Age ≥ 16 years
  • Life expectancy of more than 3 months
  • ECOG performance status ≤ 2
  • Adequate bone marrow function (ANC≥1,500/mm3, and platelet count ≥100,000/mm3)
  • Adequate kidney function (serum creatinine ≤ 1.5 mg/dL)
  • Adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or < 5 times for patients with liver metastasis, serum alkaline phosphatase < 2.5 times the upper normal limit, or < 5 times if liver metastases were present or < 10 times if bone metastases were present).
  • Adequate cardiac function (Ejection fraction ≥ 50% by echoCG or MUGA scan)
  • All patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment.

Exclusion Criteria:

  • Pregnant or lactating patients
  • Patients with resectable lung metastasis
  • Presence or history of CNS metastasis
  • Prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix
  • Any preexisting medical condition of sufficient severity to prevent full compliance with the study.

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): NCT00807261

Sponsors and Collaborators
Asan Medical Center
Severance Hospital
Korea University Anam Hospital
Samsung Medical Center
Principal Investigator: Jin-hee Ahn AIDS Malignancy Consortium

Responsible Party: Jin-hee Ahn / Associate Professor, AMC Identifier: NCT00807261     History of Changes
Other Study ID Numbers: DOCET_L_03981
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
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