Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy
This study is enrolling participants by invitation only.
Sponsor:
Asan Medical Center
Collaborators:
Severance Hospital
Korea University Anam Hospital
Samsung Medical Center
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00807261
First received: December 10, 2008
Last updated: December 11, 2008
Last verified: December 2008
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Purpose
To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide
- Primary endpoint: response rate
- Secondary endpoint: progress-free survival, overall survival, safety
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: Gemcitabine and Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Gemcitabine and Docetaxel
- Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8)
- Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days
- 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.
Drug and schedule
Dose modification
Patients with response or no change will receive 2 additional cycles.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jin-hee Ahn / Associate Professor, AMC |
| ClinicalTrials.gov Identifier: | NCT00807261 History of Changes |
| Other Study ID Numbers: | DOCET_L_03981 |
| Study First Received: | December 10, 2008 |
| Last Updated: | December 11, 2008 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gemcitabine Docetaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013