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
18 Years
70 Years
Both
Sarcoma
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Ole S. Nielsen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Aarhus Universitetshospital - Aarhus Sygehus
Authority:
United States: Federal Government
Study ID:
EORTC-62002
NCT ID:
NCT00030784
Start Date:
November 2001
Completion Date:
Related Keywords:
- Sarcoma
- 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
- Sarcoma
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