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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00410462 |
Purpose
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 |
|---|---|---|
|
Ovarian Cancer Sarcoma Small Intestine Cancer |
Drug: brostallicin Drug: doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Study Chair: | Hans Gelderblom, MD, PhD | Leiden University Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00410462 History of Changes |
| Other Study ID Numbers: | CDR0000520404, EORTC-62061, EUDRACT-2006-001861-40, NERVIANO-BRTA-0100-015 |
| Study First Received: | December 11, 2006 |
| Last Updated: | July 10, 2010 |
| 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 |
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Ovarian Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Sarcoma Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |