Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy
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|ClinicalTrials.gov 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
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 or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Gemcitabine and Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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
Patients with response or no change will receive 2 additional cycles.
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 ClinicalTrials.gov identifier (NCT number): NCT00807261
|Principal Investigator:||Jin-hee Ahn||AIDS Malignancy Consortium|