Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissu… (NCT00030784) | Clinical Trial Compass
CompletedPhase 1
Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Denmark, Germany28 participantsStarted 2001-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 tre…
Trial details
NCT IDNCT00030784
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC