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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00189137
First received: September 13, 2005
Last updated: November 6, 2015
Last verified: November 2015
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Patients Hospitalized in Each Arm. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Percentage of Patients Alive Without Disease at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Disease-free survival


Enrollment: 84
Study Start Date: August 2004
Study Completion Date: October 2015
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: doxorubicin and ifosfamide Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

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.

Experimental: gemcitabine and docetaxel Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

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.


Detailed Description:

The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

  Eligibility

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Scott Schuetze, MD, PhD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00189137     History of Changes
Other Study ID Numbers: UMCC 2004.010  HUM 44800 
Study First Received: September 13, 2005
Results First Received: November 17, 2014
Last Updated: November 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Doxorubicin
Docetaxel
Isophosphamide mustard
Liposomal doxorubicin
Ifosfamide
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 24, 2016