Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00030784

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : September 24, 2012

Sponsor:

Information provided by (Responsible Party):

European Organisation for Research and Treatment of Cancer - EORTC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sarcoma	Drug: ifosfamide Drug: pegylated liposomal doxorubicin hydrochloride	Phase 1

Detailed Description:

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
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
Study Start Date :	November 2001
Actual Primary Completion Date :	March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ifosfamide Doxorubicin Doxorubicin hydrochloride

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Liposarcoma Synovial Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Undifferentiated Pleomorphic Sarcoma Fibrosarcoma Alveolar Soft Part Sarcoma Epithelioid Sarcoma Hemangiopericytoma Malignant Mesenchymoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00030784 History of Changes
Other Study ID Numbers:	EORTC-62002
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	September 24, 2012
Last Verified:	September 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

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