Clinical trial NCT00041236: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 39
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Aarhus
country: Denmark
facility: Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
city: Berlin
country: Germany
facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carl Carus
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hamburg
country: Germany
facility: Universitaets-Krankenhaus Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Tuebingen
country: Germany
facility: Eberhard Karls Universitaet
city: Bratislava
country: Slovakia
facility: National Cancer Institute - Bratislava
Study officials:
affiliation: Robert Roessle Klinik
name: Peter Reichardt, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.