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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.
 
ClinicalTrials.gov Identifier: NCT00030784
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE November 2001
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Official Title  ICMJE 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
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE
  • Drug: ifosfamide
  • Drug: pegylated liposomal doxorubicin hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September¬†20,¬†2012)
28
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030784
Other Study ID Numbers  ICMJE EORTC-62002
EORTC-62002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ole S. Nielsen, MD Aarhus Universitetshospital - Aarhus Sygehus
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP