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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410462 |
RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.
Condition | Intervention | Phase |
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Ovarian Cancer Sarcoma Small Intestine Cancer |
Drug: brostallicin Drug: doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma |
Estimated Enrollment: | 108 |
Study Start Date: | October 2006 |
OBJECTIVES:
Primary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over).
Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma* of 1 of the following cellular types:
The following tumor types are excluded:
PATIENT CHARACTERISTICS:
No serious cardiac illness within the past 6 months, including, but not limited to the following:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer therapy or investigational agents, including any of the following:
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC |
Study Chair: | Hans Gelderblom, MD, PhD | Leiden University Medical Center |
Study ID Numbers: | CDR0000520404, EORTC-62061, EUDRACT-2006-001861-40, NERVIANO-BRTA-0100-015 |
Study First Received: | December 11, 2006 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00410462 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma adult liposarcoma adult fibrosarcoma adult malignant fibrous histiocytoma adult leiomyosarcoma adult rhabdomyosarcoma adult alveolar soft-part sarcoma adult malignant mesenchymoma |
adult angiosarcoma adult epithelioid sarcoma adult neurofibrosarcoma adult synovial sarcoma recurrent uterine sarcoma stage IV uterine sarcoma ovarian sarcoma small intestine leiomyosarcoma recurrent small intestine cancer |
Fibrosarcoma Histiocytoma, Malignant Fibrous Gastrointestinal Diseases Histiocytoma, Benign Fibrous Leiomyosarcoma Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ileal Diseases Malignant Fibrous Histiocytoma Sarcoma, Synovial Duodenal Neoplasms Genital Diseases, Female Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue |
Soft Tissue Sarcomas Epithelioid Sarcoma Ileal Neoplasms Ovarian Cancer Synovial Sarcoma Sarcoma, Alveolar Soft Part Alveolar Soft Part Sarcoma Duodenal Diseases Rhabdomyosarcoma Endocrine Gland Neoplasms Jejunal Neoplasms Digestive System Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases |
Antineoplastic Agents Gonadal Disorders Gastrointestinal Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Ileal Diseases Genital Diseases, Female Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Duodenal Diseases |
Endocrine Gland Neoplasms Jejunal Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Intestinal Diseases Pharmacologic Actions Doxorubicin Intestinal Neoplasms Adnexal Diseases Neoplasms Digestive System Diseases Sarcoma |