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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ifosfamide

pegylated liposomal doxorubicin hydrochloride

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00030784

First Posted

February 14, 2002

Last Updated

September 20, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT00030784

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ifosfamide

Intervention Type

Drug

Intervention Name(s)

pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole S. Nielsen, MD

Organizational Affiliation

Aarhus Universitetshospital - Aarhus Sygehus

Official's Role

Study Chair

Facility Information:

Facility Name

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

City

Aarhus

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

City

Berlin

ZIP/Postal Code

D-13122

Country

Germany

Sarcoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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