Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma

This study is currently recruiting participants.

Verified by University of Michigan Cancer Center, July 2008

First Received: September 13, 2005 Last Updated: July 24, 2008 History of Changes

Sponsored by:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00189137

Purpose

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.

Condition	Intervention	Phase
Sarcoma, Soft Tissue	Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Gemcitabine Myocet Docetaxel Gemcitabine hydrochloride Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma

Further study details as provided by University of Michigan Cancer Center:

Estimated Enrollment:	80
Study Start Date:	August 2004
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

no evidence of metastasis
greater than 5 cm
adjuvant or neoadjuvant
Zubrod performance status 1 or better
age 10 or older

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189137

Contacts

Contact: Cancer Answer Line

1-800-865-1125

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Mark Zalupski, MD

Sponsors and Collaborators

University of Michigan Cancer Center

Investigators

Principal Investigator:

Mark M Zalupski, MD

University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan Health Systems ( Dr. Mark Zalupski )
Study ID Numbers:	UMCC 2004.010
Study First Received:	September 13, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00189137 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Docetaxel
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Malignant Mesenchymal Tumor

Soft Tissue Sarcomas
Ifosfamide
Radiation-Sensitizing Agents
Sarcoma
Antineoplastic Agents, Alkylating
Gemcitabine
Alkylating Agents
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Antiviral Agents

Doxorubicin
Pharmacologic Actions
Docetaxel
Neoplasms, Connective and Soft Tissue
Neoplasms
Ifosfamide
Radiation-Sensitizing Agents
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Gemcitabine
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009