NCT00030784

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

February 14, 2002

Last Update Submit

September 20, 2012

Conditions

Sarcoma

Keywords

adult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult neurofibrosarcomaadult synovial sarcomastage III adult soft tissue sarcomaadult alveolar soft-part sarcomaadult epithelioid sarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomaadult rhabdomyosarcomastage IV adult soft tissue sarcoma

Interventions

ifosfamideDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, DK-8000, Denmark

Location

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

Berlin, D-13122, Germany

Location

MeSH Terms

Conditions

SarcomaHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaNeurofibrosarcomaSarcoma, SynovialSarcoma, Alveolar Soft PartHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorRhabdomyosarcoma

Interventions

Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Muscle TissueNeoplasms, Adipose TissueNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesHistiocytomaMyosarcoma

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ole S. Nielsen, MD

    Aarhus Universitetshospital - Aarhus Sygehus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

March 1, 2005

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

DK(1)DE(1)