Working… Menu

Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030784
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: ifosfamide Drug: pegylated liposomal doxorubicin hydrochloride Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma.
  • Determine the objective response in patients treated with this regimen.
  • Determine the dose-limiting toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Primary Purpose: Treatment
Official Title: Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas
Study Start Date : November 2001
Actual Primary Completion Date : March 2005

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed soft tissue sarcoma

    • Advanced and/or metastatic disease
    • Must be of any of the following types:

      • Malignant fibrous histiocytoma
      • Liposarcoma (excluding lipomas and well-differentiated liposarcomas)
      • Rhabdomyosarcoma
      • Synovial sarcoma
      • Malignant paraganglioma
      • Fibrosarcoma
      • Leiomyosarcoma
      • Angiosarcoma
      • Neurogenic sarcoma
      • Sarcoma not otherwise specified
    • Paraffin blocks and slides must be available
  • Measurable disease

    • Osseous lesions and pleural effusions are not considered measurable disease
  • Evidence of progressive disease within the past 6 weeks
  • The following conditions are excluded:

    • Gastrointestinal stromal tumors
    • Malignant mesothelioma
    • Chondrosarcoma
    • Neuroblastoma
    • Osteosarcoma
    • Ewing's sarcoma
    • Embryonal rhabdomyosarcoma
  • No symptomatic or known CNS metastases



  • 18 to 70

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.75 mg/dL
  • Albumin at least 2.5 g/dL


  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance at least 65 mL/min


  • Ejection fraction at least 50% by echocardiogram or isotopic methods
  • No history of cardiovascular disease


  • No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
  • No other severe medical illness
  • No psychosis
  • No psychological, familial, sociological, or geographical condition that would preclude study participation
  • Not pregnant
  • Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation


Biologic therapy:

  • Not specified


  • No prior chemotherapy for advanced disease
  • No other concurrent systemic chemotherapy for malignancy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to sole indicator lesion
  • Concurrent radiotherapy allowed except to sole indicator lesion


  • Not specified


  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030784

Layout table for location information
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, Denmark, DK-8000
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Layout table for investigator information
Study Chair: Ole S. Nielsen, MD Aarhus Universitetshospital - Aarhus Sygehus
Layout table for additonal information
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00030784    
Other Study ID Numbers: EORTC-62002
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma
stage III adult soft tissue sarcoma
adult alveolar soft-part sarcoma
adult epithelioid sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult rhabdomyosarcoma
stage IV adult soft tissue sarcoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents