SarcomaPhase 2NCT00041236
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
A Phase 2 study testing exatecan mesylate in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 4 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- exatecan mesylate
- How many people
- 39 participants
- Where
- 10 sitesin 4 countries
- Study dates
- May 2002to Dec 2004
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma
- Malignant fibrous histiocytoma
- Liposarcoma
- Rhabdomyosarcoma
- Synovial sarcoma
- Malignant paraganglioma
- Fibrosarcoma
- Leiomyosarcoma
- Angiosarcoma including hemangiopericytoma
- Malignant peripheral nerve sheath tumor
- Unclassified sarcoma
- Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
- The following tumor types are excluded:
- Gastrointestinal stromal tumor
- Chondrosarcoma
- Malignant mesothelioma
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma
- Embryonal rhabdomyosarcoma
- Prior chemotherapy for metastatic disease required
- One line of combination chemotherapy containing anthracycline OR
- No more than 2 single-agent regimens including anthracycline
- Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
- Must have 1 measurable lesion
- Clinical evidence of progression within 6 weeks prior to study
- Osseous lesions and pleural effusions not considered measurable
- No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 15 to 75
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 1.8 mg/dL
- Albumin at least 2.5 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance greater than 65 mL/min
Cardiovascular:
- No history of severe cardiovascular disease
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 6 months after study participation
- No other severe medical illness, including psychosis
- No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- No other concurrent cytotoxic therapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No radiotherapy to the sole measurable lesion
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
- No other concurrent anticancer therapy
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany6 sites
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, D-13122
Universitatsklinikum Carl Gustav Carl Carus
Dresden, D-01307
Universitaetsklinikum Essen
Essen, D-45122
Universitaets-Krankenhaus Eppendorf
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Eberhard Karls Universitaet
Tübingen, D-72076
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
U.Z. Gasthuisberg
Leuven, B-3000
Denmark1 site
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, DK-8000
About this study
Official title: Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
Read the detailed description
OBJECTIVES:
- Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.
- Conditions
- Sarcoma
- Being tested
- exatecan mesylate
- Keywords
- adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult rhabdomyosarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma
- Medical subject headings
- Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial, Histiocytoma, Malignant Fibrous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exatecan mesylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Peter Reichardt, MD, Study chair, Robert Roessle Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041236
- Sponsor's protocol ID
- EORTC-62006
- Other IDs
- EORTC-62006
- Status last verified
- Jul 2012
- First submitted
- 8 Jul 2002
- Last updated
- 18 Jul 2012
- Results posted
- No
Publications
Reichardt P, Nielsen OS, Bauer S, Hartmann JT, Schoffski P, Christensen TB, Pink D, Daugaard S, Marreaud S, Van Glabbeke M, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Apr;43(6):1017-22. doi: 10.1016/j.ejca.2007.01.014. Epub 2007 Mar 1.
PubMed 17336054Pink D, Reichardt P, Nielsen OS, et al.: Exatecan (DX-8951f), a new topoisomerase I - inhibitor, is inactive in heavily pretreated patients (pts.) with advanced soft tissue sarcoma (STS): a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-9058, 830s, 2005.