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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030784
• Other study ID #: EORTC-62002
• Secondary ID: EORTC-62002
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2002
• Last updated: September 20, 2012
• Start date: November 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• ifosfamide

• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital - Aarhus Sygehus - Norrebrogade	Aarhus
Germany	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Denmark,  Germany,