NCT00189137

Brief Summary

The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_2

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 7, 2015

Status Verified

November 1, 2015

Enrollment Period

8.3 years

First QC Date

September 13, 2005

Results QC Date

November 17, 2014

Last Update Submit

November 6, 2015

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Hospitalized in Each Arm.

    To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.

    12 weeks

Secondary Outcomes (1)

  • The Percentage of Patients Alive Without Disease at 2 Years

    2 years

Study Arms (2)

doxorubicin and ifosfamide

ACTIVE COMPARATOR
Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

gemcitabine and docetaxel

EXPERIMENTAL
Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

Interventions

ifosfamide and doxorubicin vs gemcitabine and docetaxelDRUG

Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.

doxorubicin and ifosfamidegemcitabine and docetaxel

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • no evidence of metastasis
  • soft tissue sarcoma
  • intermediate or high histologic grade
  • greater than 5 cm
  • Zubrod performance status 1 or better
  • age 10 or older

You may not qualify if:

  • clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
  • prior chemotherapy
  • nephrectomy
  • active unstable angina pectoris
  • concurrent therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Davis EJ, Zhao L, Lucas DR, Schuetze SM, Baker LH, Zalupski MM, Thomas D, Chugh R. SPARC expression in patients with high-risk localized soft tissue sarcoma treated on a randomized phase II trial of neo/adjuvant chemotherapy. BMC Cancer. 2016 Aug 20;16:663. doi: 10.1186/s12885-016-2694-2.

    PMID: 27544129DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

IfosfamideDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Results Point of Contact

Title
Dr. Scott Schuetze, M.D., Ph.D.
Organization
University of Michigan Comprehensive Cancer Center
scotschu@umich.edu
1-800-865-1125

Study Officials

  • Scott Schuetze, MD, PhD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2012

Study Completion

October 1, 2015

Last Updated

December 7, 2015

Results First Posted

November 24, 2014

Record last verified: 2015-11

Locations

US(1)