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Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Sarcoma | Drug: ifosfamide Drug: pegylated liposomal doxorubicin hydrochloride | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 28 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00030784
| Denmark | |
| Aarhus University Hospital - Aarhus Sygehus - Norrebrogade | |
| Aarhus, Denmark, DK-8000 | |
| Germany | |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | |
| Berlin, Germany, D-13122 | |
| Study Chair: | Ole S. Nielsen, MD | Aarhus Universitetshospital - Aarhus Sygehus |
More Information
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00030784 History of Changes |
| Other Study ID Numbers: |
EORTC-62002 |
| Study First Received: | February 14, 2002 |
| Last Updated: | September 20, 2012 |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
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 |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Liposomal doxorubicin Isophosphamide mustard Ifosfamide |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on June 23, 2017