Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Phase 1

Completed

• Conditions: Stage III Adult Soft Tissue Sarcoma
• Interventions: Drug: Gemcitabine; Drug: Docetaxel; Drug: Pazopanib

• Registration Number: NCT01719302
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-11-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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:

  1. absolute peripheral granulocyte count of >1500 cells/mm^3
  2. hemoglobin >8.0 g/dl
  3. platelet count >100,000/mm^3
  4. absence of a regular red blood cell transfusion requirement

• adequate hepatic function defined by:

  1. total bilirubin <1.5 x upper limit of normal (ULN)
  2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN

• adequate renal function defined by:

  1. serum creatinine <1.5 x ULN

• negative pregnancy test for women of child bearing potential

• willingness to use effective contraception while on treatment and for 3 months thereafter

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort 1	Gemcitabine	-
cohort 1	Pazopanib	-
cohort 1	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	1 cycle (28 days)

Secondary Outcome Measures

Name	Time	Method
Overall response rate	4 cycles (112 days)

Trial Locations

Locations (1)

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States