Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ifosfamide | Drug | Ifosfamide | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 drugsReferences
Publications (0)
Data not yet available