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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | September 10, 2003 | ||||||||||||
| Last Updated Date | July 23, 2008 | ||||||||||||
| Start Date ICMJE | December 2003 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
Tumor response as assessed by RECIST radiographic criteria [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Tumor response as assessed by RECIST radiographic criteria | ||||||||||||
| Change History | Complete list of historical versions of study NCT00068367 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Toxicity as assessed by CTCAE [ Designated as safety issue: Yes ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE |
Toxicity as assessed by CTCAE | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor | ||||||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||||||
| Condition ICMJE | Sarcoma | ||||||||||||
| Intervention ICMJE | Drug: erlotinib hydrochloride | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Enrollment ICMJE | |||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | 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 ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00068367 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | CDR0000322023, SWOG-S0330 | ||||||||||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | January 2006 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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