Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Stage III Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719302
• Other study ID #: VCC 1202
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 29, 2012
• Last updated: June 14, 2016
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2016
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma
• Stage III Adult Soft Tissue Sarcoma

Intervention

Drug:
• Gemcitabine
1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
• Docetaxel
50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
• Pazopanib
Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		1 cycle (28 days)
Secondary	Overall response rate		4 cycles (112 days)