A Phase Ib/II Study of Gemcitabine and Docetaxel Plus Pazopanib for the Neoadjuvant (Presurgical) Treatment of Soft-Tissue Sarcoma

Protocol
11-104
Full Title
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)
Phase
I/II
Purpose

Soft-tissue sarcoma of an arm or leg (extremity) is usually treated with surgery, sometimes followed by radiation therapy. Adding chemotherapy to this treatment combination may further reduce the risk of recurrence and help facilitate a better surgery.

Gemcitabine and docetaxel are chemotherapy drugs used in the standard treatment of soft-tissue sarcoma. However, sometimes the tumor returns despite these drugs. Pazopanib is a drug approved for treating kidney cancer that has shown promise in phase II and III clinical trials for the treatment of advanced sarcoma.

The purpose of this study is to determine if adding pazopanib to standard chemotherapy (gemcitabine and docetaxel) will reduce the risk of cancer recurrence after surgery. In addition, the study will identify the dose of pazopanib that can be given safely with gemcitabine and docetaxel in patients with soft-tissue sarcoma who receive this combination chemotherapy before surgery.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have localized high-grade soft-tissue sarcoma of an extremity that can be surgically removed.
  • This study is limited to patients who have malignant peripheral nerve sheath tumors, leiomyosarcomas, and malignant fibrous histiocytomas.
  • Patients may not have had prior radiation or chemotherapy for their sarcoma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tap at 646-888-4163.

Disease(s)
Sarcomas
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases