Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
This study has been completed.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00030784
First received: February 14, 2002
Last updated: September 20, 2012
Last verified: September 2012
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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 |
Resource links provided by NLM:
MedlinePlus related topics:
Soft Tissue Sarcoma
Genetic and Rare Diseases Information Center resources:
Alveolar Soft Part Sarcoma
Dermatofibroma
Epithelioid Sarcoma
Fibrosarcoma
Hemangiopericytoma
Leiomyosarcoma
Liposarcoma
Malignant Fibrous Histiocytoma
Malignant Mesenchymal Tumor
Malignant Peripheral Nerve Sheath Tumor
Neurofibrosarcoma
Soft Tissue Sarcoma
Synovial Sarcoma
U.S. FDA Resources
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030784
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030784
Locations
| 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 | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Ole S. Nielsen, MD | Aarhus Universitetshospital - Aarhus Sygehus |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00030784 History of Changes |
| Other Study ID Numbers: | EORTC-62002, EORTC-62002 |
| Study First Received: | February 14, 2002 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
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 Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Doxorubicin Ifosfamide Isophosphamide mustard Liposomal doxorubicin Alkylating Agents |
Antibiotics, Antineoplastic Antineoplastic Agents Antineoplastic Agents, Alkylating Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015