NCT00880542

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with ifosfamide may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with ifosfamide and to see how well it works in treating patients with high-grade soft tissue sarcoma or bone sarcoma that can be removed by surgery.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
6 months until next milestone

Results Posted

Study results publicly available

May 10, 2011

Completed
Last Updated

August 10, 2020

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

April 10, 2009

Results QC Date

April 13, 2011

Last Update Submit

July 29, 2020

Conditions

Sarcoma

Keywords

localized osteosarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.

    After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.

    Participants were followed for duration of study, an average of 1 year.

Secondary Outcomes (1)

  • Local and Distant Recurrence-free Survival

    conclusion of study

Study Arms (1)

Sorafenib + Ifosfamide

EXPERIMENTAL

\* Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days\* for 3 courses. NOTE: \*Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration. * Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery. * Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.

Drug: sorafenibDrug: Ifosfamide

Interventions

sorafenibDRUG

Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy.

Sorafenib + Ifosfamide
IfosfamideDRUG

Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy.

Sorafenib + Ifosfamide

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed high grade sarcoma of the soft tissue or bone
  • participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy
  • candidates must have operable disease for which a resection is planned
  • ECOG performance status 0-1
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
  • INR \< 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or heparin allowed
  • Creatinine ≤ 1.5 times ULN
  • women of childbearing potential must have negative pregnancy test performed within 7 days prior to start of treatment.
  • Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy.
  • A signed informed consent must be obtained prior to any study specific procedures.

You may not qualify if:

  • known HIV infection
  • chronic hepatitis B or C infection
  • clinically active serious infection \> CTCAE grade 2
  • NYHA class III or IV congestive heart failure
  • unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3 months
  • myocardial infarction within the past 6 months
  • cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) despite optimal medical management
  • thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
  • other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
  • Any condition that would impair the ability to swallow whole pills
  • malabsorption problem
  • Any known severe hypersensitivity to sorafenib tosylate or any of its excipients
  • known or suspected allergy to sorafenib tosylate or any agent given in this study
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

SorafenibIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazines

Limitations and Caveats

This study lost funding and was not able to enroll enough participants to do a complete review.

Results Point of Contact

Title
William Tap, MD
Organization
University of Calicornia Los Angeles (UCLA)
wtap@mednet.ucla.edu
888-798-0719

Study Officials

  • William Tap, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

August 1, 2008

Primary Completion

November 1, 2010

Last Updated

August 10, 2020

Results First Posted

May 10, 2011

Record last verified: 2012-07

Locations

US(1)