Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00041236

Collaborator

(none)

Enrollment

Locations

3.9

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: exatecan mesylate	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 and Locations

Locations

	Site	City	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels	Belgium	1200
2	U.Z. Gasthuisberg	Leuven	Belgium	B-3000
3	Aarhus University Hospital - Aarhus Sygehus - Norrebrogade	Aarhus	Denmark	DK-8000
4	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch	Berlin	Germany	D-13122
5	Universitatsklinikum Carl Gustav Carl Carus	Dresden	Germany	D-01307
6	Universitaetsklinikum Essen	Essen	Germany	D-45122
7	Universitaets-Krankenhaus Eppendorf	Hamburg	Germany	D-20246
8	Medizinische Hochschule Hannover	Hannover	Germany	D-30625
9	Eberhard Karls Universitaet	Tuebingen	Germany	D-72076
10	National Cancer Institute - Bratislava	Bratislava	Slovakia	833 10