A Phase 1/2 interventional study of Gemcitabine and Docetaxel in Stage III Adult Soft Tissue Sarcoma, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.
Sponsored by University of Vermont · Phase 1/2, Interventional, and Treatment
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.
The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
adequate bone marrow function defined by:
adequate hepatic function defined by:
adequate renal function defined by:
Exclusion Criteria:
Drug: Gemcitabine · Drug: Docetaxel · Drug: Pazopanib
1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Also known as: Gemzar
50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
Also known as: Taxotere
Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.
Also known as: Votrient
Maximum Tolerated Dose
Time frame: 1 cycle (28 days)
Overall response rate
Time frame: 4 cycles (112 days)
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Vermont