Clinical Trial NU MSK12S01
- 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)
- Principal Investigator
- Mark Agulnik
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MSK12S01
- The purpose of this study is to find out what effects (good and/or bad)the combination of gemcitabine, docetaxel and pazopanib has on soft tissue sarcoma (STS).
- The standard treatment for extremity sarcoma (in the soft tissue) is surgical resection (removal of the tumor). This is usually followed by radiation therapy. Sometimes the cancer comes back (recurrence). Recently, it has been suggested that chemotherapy may help to reduce the recurrence of sarcoma. Gemcitabine and docetaxel is a commonly used drug combination used for the treatment of advanced soft tissue sarcomas. Pazopanib can be effective treating advanced sarcoma in cases where prior chemotherapy was received. Combining these 3 drugs together is experimental.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must sarcoma in an extremity (arms or legs).
- Participants must have cancer that may be removed with surgery.
- Description of Treatment
- All participants will receive the same dose of gemcitabine and docetaxel. Depending on when they enroll they will receive one of three possible doses of pazopanib. Participants will receive 2 cycles (each cycle is 21 days). After 2 cycles of treatment participants will be assessed. If the treatment is helping then they will receive 2 more cycles. If the cancer appears to be growing, then no further treatment will be given. In either case, surgery will follow treatment with participants receiving radiation therapy after that.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- TPF Induction chemotherapy and ABT-888 (Veliparib) – a Phase 1/Randomized Phase 2 Study in Patients w/ Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- A Phase II Randomized, Double Blinded Study of the Peroxisome Proliferator-Activated Receptor Gamma Agonist, Efatutazone vs. Placebo in Patients with Previously Treated, Unresectable Myxoid Liposarcoma
- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
- Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination with Tremelimumab or Tremelimumab Alone in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Phase 2 Efficacy and Safety Study of Intravenous GPX-150, an Anthracycline Analog, in Patients with Soft Tissue Sarcoma
- An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients with Advanced Soft Tissue Sarcoma
- A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
last updated: 06-Oct-15 01:09 AM
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