Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
Overview
- Phase
- Phase 1
- Intervention
- Gemcitabine
- Conditions
- Stage III Adult Soft Tissue Sarcoma
- Sponsor
- University of Vermont
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Claire Verschraegen
Director, Hematology Oncology Unit
University of Vermont
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
- •tumor greater than 5 cm in longest dimension
- •life expectancy of at least 6 months
- •Zubrod performance status of 0-2
- •signed informed consent
- •adequate bone marrow function defined by:
- •absolute peripheral granulocyte count of \>1500 cells/mm\^3
- •hemoglobin \>8.0 g/dl
- •platelet count \>100,000/mm\^3
Exclusion Criteria
- •Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
- •Pregnant women or nursing mothers
- •concurrent chemotherapy or radiation therapy
- •severe medical problems (at the discretion of the investigator)
- •history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •symptomatic brain metastases
- •cirrhosis
- •dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)
Arms & Interventions
cohort 1
Intervention: Gemcitabine
cohort 1
Intervention: Docetaxel
cohort 1
Intervention: Pazopanib
Outcomes
Primary Outcomes
Maximum Tolerated Dose
Time Frame: 1 cycle (28 days)
Secondary Outcomes
- Overall response rate(4 cycles (112 days))