Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00030784
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2001-11-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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ifosfamide
pegylated liposomal doxorubicin hydrochloride
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Ole S. Nielsen, MD
Role: STUDY_CHAIR
Aarhus Universitetshospital - Aarhus Sygehus
Locations
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Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, , Denmark
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Countries
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Other Identifiers
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EORTC-62002
Identifier Type: -
Identifier Source: secondary_id
EORTC-62002
Identifier Type: -
Identifier Source: org_study_id