Clinical Trial: S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.


Detailed Summary:

OBJECTIVES:

  • Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function (e.g., expression, phosphorylation, or markers of signal transduction downstream of EGFR) with response and progression-free and overall survival in patients treated with this drug.
  • Determine the feasibility of accruing these patients in the cooperative group setting.

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.


Sponsor: Southwest Oncology Group

Current Primary Outcome: Tumor response as assessed by RECIST radiographic criteria [ Time Frame: every eight weeks during treatment ]

x-rays and scans


Original Primary Outcome:

Current Secondary Outcome: Toxicity as assessed by CTCAE [ Time Frame: every two weeks for two cycles and then every four weeks ]

Original Secondary Outcome:

Information By: Southwest Oncology Group

Dates:
Date Received: September 10, 2003
Date Started: December 2003
Date Completion:
Last Updated: January 13, 2012
Last Verified: January 2012