Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
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|ClinicalTrials.gov Identifier: NCT00227669|
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : August 30, 2016
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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: gemcitabine hydrochloride
- Anti-tumoral activity (objective response rate) [ Time Frame: 6 months ]
- Progression-free survival [ Time Frame: 6 months ]
- Response duration [ Time Frame: 3 years ]
- Tolerability [ Time Frame: 3 years ]
- Dose intensity [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]
- Biological markers [ Time Frame: 3 years ]
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): NCT00227669
|Study Chair:||Florence Duffaud, MD||CHU de la Timone|