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| Descriptive Information Fields | |||||||||||||
| Brief Title † | Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor | ||||||||||||
| Official Title † | U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II | ||||||||||||
| Brief Summary | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Open Label | ||||||||||||
| Primary Outcome Measure † | Tumor response as assessed by RECIST radiographic criteria [ Designated as safety issue: No ] | ||||||||||||
| Secondary Outcome Measure † | Toxicity as assessed by CTCAE [ Designated as safety issue: Yes ] | ||||||||||||
| Condition † | Sarcoma | ||||||||||||
| Intervention † | Drug: erlotinib hydrochloride | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Active, not recruiting | ||||||||||||
| Enrollment † | |||||||||||||
| Start Date † | December 2003 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00068367 | ||||||||||||
| Organization ID | CDR0000322023 | ||||||||||||
| Secondary IDs †† | SWOG-S0330 | ||||||||||||
| Study Sponsor † | Southwest Oncology Group | ||||||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | January 2006 | ||||||||||||
| First Received Date † | September 10, 2003 | ||||||||||||
| Last Updated Date | July 23, 2008 | ||||||||||||