Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01719302

Enrollment

Registered

2012-11-01

Start date

2012-10-31

Completion date

2015-04-30

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Adult Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma, gemcitabine, docetaxel, pazopanib

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.

Interventions

DRUGGemcitabine

1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles

DRUGDocetaxel

50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles

DRUGPazopanib

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose	1 cycle (28 days)

Secondary

Measure	Time frame
Overall response rate	4 cycles (112 days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026