NCT00002526

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 II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Jan 1993

Geographic Reach
1 country

1 active site

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

January 1, 1993

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

March 11, 2004

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.7 years

First QC Date

November 1, 1999

Last Update Submit

May 14, 2012

Conditions

Ovarian CancerSarcoma

Keywords

stage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcomaovarian sarcomastage IV adult soft tissue sarcoma

Interventions

filgrastimBIOLOGICAL
doxorubicin hydrochlorideDRUG
ifosfamideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven advanced soft tissue or gynecologic sarcoma Measurable disease No brain metastases (CT scan required if metastases are clinically suspected) PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal Albumin 4.0-6.0 g/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal by MUGA scan or echocardiogram Other: No other prior or concurrent malignancy except radically removed nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder No prior radiotherapy to indicator lesion Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (1)

  • Leyvraz S, Zweifel M, Jundt G, Lissoni A, Cerny T, Sessa C, Fey M, Dietrich D, Honegger HP; Swiss Group for Clinical Cancer Research. Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. Ann Oncol. 2006 Apr;17(4):646-51. doi: 10.1093/annonc/mdl020. Epub 2006 Feb 24.

    PMID: 16500907RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsSarcoma

Interventions

FilgrastimDoxorubicinIfosfamide

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Serge Leyvraz, MD

    Centre Hospitalier Universitaire Vaudois

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 11, 2004

Study Start

January 1, 1993

Primary Completion

September 1, 1995

Study Completion

September 1, 1995

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(1)