Trials / Terminated
TerminatedNCT01418001
Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
A Phase IB/II Study of Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see the effects, good and/or bad, of the drug combination of gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial. The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is safe. The investigators determine this by closely checking for side effects that the patient may experience.
Conditions
- Sarcoma
- Leiomyosarcoma
- Malignant Peripheral Nerve Sheath Tumor
- Malignant Fibrous
- Histiocytoma/Undifferentiated Pleomorphic Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination | Patients who meet the eligibility criteria above will be treated with the combination therapy of Gemcitabine, Docetaxel, and Pazopanib for two cycles and subsequently re-evaluated for treatment effect. If no progression of the tumor is seen, patients will continue with two more cycles of treatment (total four cycles). Those patients who have progression of disease will proceed directly to surgical resection. Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy. Patients will then be followed for 2 years or until January 1st 2015, whichever comes first . |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2011-08-16
- Last updated
- 2018-01-11
- Results posted
- 2016-02-17
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01418001. Inclusion in this directory is not an endorsement.