NCT01719302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

October 29, 2012

Last Update Submit

June 14, 2016

Conditions

Stage III Adult Soft Tissue Sarcoma

Keywords

Soft tissue sarcomagemcitabinedocetaxelpazopanib

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    1 cycle (28 days)

Secondary Outcomes (1)

  • Overall response rate

    4 cycles (112 days)

Study Arms (1)

cohort 1

EXPERIMENTAL
Drug: GemcitabineDrug: DocetaxelDrug: Pazopanib

Interventions

GemcitabineDRUG

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

Also known as: Gemzar
cohort 1
DocetaxelDRUG

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

Also known as: Taxotere
cohort 1
PazopanibDRUG

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.

Also known as: Votrient
cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • absence of a regular red blood cell transfusion requirement
  • adequate hepatic function defined by:
  • total bilirubin \<1.5 x upper limit of normal (ULN)
  • AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
  • adequate renal function defined by:
  • +3 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

GemcitabineDocetaxelpazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hematology Oncology Unit

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

US(1)