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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00030784
First received: February 14, 2002
Last updated: September 20, 2012
Last verified: September 2012

February 14, 2002
September 20, 2012
November 2001
March 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00030784 on ClinicalTrials.gov Archive Site
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Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Sarcoma
  • Drug: ifosfamide
  • Drug: pegylated liposomal doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Not Provided
March 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany
 
NCT00030784
EORTC-62002, EORTC-62002
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Ole S. Nielsen, MD Aarhus Universitetshospital - Aarhus Sygehus
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

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