History of Changes for Study: NCT00041236

Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

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Study Record Versions

Version	Submitted Date	Changes
1	June 23, 2005	None (earliest Version on record)
2	February 20, 2007	Study Status, Study Identification, References, Eligibility, Study Design and Conditions
3	March 20, 2007	References and Study Status
4	August 6, 2007	Study Status
5	October 25, 2007	Study Status
6	November 16, 2007	Study Status
7	December 15, 2007	Study Status
8	December 25, 2007	Study Status
9	January 5, 2008	Study Status
10	January 12, 2008	Study Status
11	January 20, 2008	Study Status
12	March 1, 2008	Study Status
13	March 8, 2008	Study Status
14	May 23, 2008	Arms and Interventions and Study Status
15	July 23, 2008	Study Status
16	July 17, 2012	Recruitment Status, Study Status, Study Identification, Contacts/Locations, Study Design, Oversight and Sponsor/Collaborators

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CDR0000069455
Brief Title:	Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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
Secondary IDs:	EORTC-62006

Study Status


Record Verification:	February 2005
Overall Status:	Active, not recruiting
Study Start:	May 2002
Primary Completion:
Study Completion:

First Submitted:	July 8, 2002
First Submitted that Met QC Criteria:	January 26, 2003
First Posted:	January 27, 2003 [Estimate]

Last Update Submitted that Met QC Criteria:	December 25, 2007
Last Update Posted:	December 27, 2007 [Estimate]

Sponsor/Collaborators


Sponsor:	European Organisation for Research and Treatment of Cancer - EORTC
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

Study Description

Brief 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.

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


Conditions:	Sarcoma
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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:
Number of Arms:
Masking:	None (Open Label)
Enrollment:

Arms and Interventions


Intervention Details:
	Drug: exatecan mesylate
	Procedure: chemotherapy

Eligibility


Minimum Age:	15 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

Contacts/Locations


Study Officials:	Peter Reichardt, MD Robert Roessle Klinik
Locations:	Belgium
	Cliniques Universitaires Saint-Luc Brussels, Belgium, 1200
	U.Z. Gasthuisberg Leuven, Belgium, B-3000
	Denmark
	Aarhus University Hospital - Aarhus Sygehus - Norrebrogade Aarhus, Denmark, DK-8000
	Germany
	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch Berlin, Germany, D-13122
	Universitatsklinikum Carl Gustav Carl Carus Dresden, Germany, D-01307
	Universitaetsklinikum Essen Essen, Germany, D-45122
	Universitaets-Krankenhaus Eppendorf Hamburg, Germany, D-20246
	Medizinische Hochschule Hannover Hannover, Germany, D-30625
	Eberhard Karls Universitaet Tuebingen, Germany, D-72076
	Slovakia
	National Cancer Institute - Bratislava Bratislava, Slovakia, 833 10

IPDSharing


Plan to Share IPD:

References


Citations:	[Study Results] 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 17336054
	[Study Results] Pink 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.
Links:
Available IPD/Information: