Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0330 S0330, NCT00068367

Special Category: CTSU trial

Objectives

1. Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
2. Determine the qualitative and quantitative toxic effects of this drug in these patients.
3. 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.
4. Determine the feasibility of accruing these patients in the cooperative group setting.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed malignant peripheral nerve sheath tumor
  • Malignant schwannoma or neurofibrosarcoma
  • Clinical evidence of unresectable or metastatic disease



• Measurable disease



• No known current CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• More than 28 days since prior biologic therapy for this malignancy

Chemotherapy

• More than 28 days since prior chemotherapy for this malignancy

Endocrine therapy

• Not specified

Radiotherapy

• More than 60 days since prior radiotherapy to the target lesion with subsequent documented progression
• More than 60 days since prior radiofrequency ablation to the target lesion with subsequent documented progression
• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior major surgery and recovered
• No prior surgical procedure affecting absorption

Other

• More than 28 days since prior investigational drugs for this malignancy
• More than 60 days since prior embolization to the target lesion with subsequent documented progression
• No prior epidermal growth factor receptor-targeting therapy
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or commercial agents or therapies for the malignancy

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver metastases)

Renal

• Creatinine no greater than 1.5 times ULN
• Creatinine clearance greater than 60 mL/min

Ophthalmic

• No known history of any of the following corneal diseases:
  • Dry eye syndrome
  • Sjögren's syndrome
  • Keratoconjunctivitis sicca
  • Exposure keratopathy
  • Fuch's dystrophy
• No other active disorders of the cornea

Gastrointestinal

• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• No active peptic ulcer disease
• No intractable nausea or vomiting
• Able to swallow medications OR receive enteral medications via gastrostomy feeding tube

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

Expected Enrollment

A total of 20-40 patients will be accrued for this study.

Outcomes

Tumor response as assessed by RECIST radiographic criteria

Toxicity as assessed by CTCAE

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.

Albritton KH, Rankin C, Coffin CM, et al.: Phase II study of erlotinib in metastatic or unresectable malignant peripheral nerve sheath tumors (MPNST). [Abstract] J Clin Oncol 24 (Suppl 18): A-9518, 524s, 2006.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Karen Albritton, MD, Study coordinator		Ph: 617-632-2545; 866-790-4500 Email: karen_albritton@dfci.harvard.edu
R. Lor Randall, MD, FACS, Study coordinator		Ph: 801-585-0300; 877-585-0303 Email: r.lor.randall@hci.utah.edu
Scott Schuetze, MD, PhD, Study coordinator		Ph: 734-647-8925; 800-865-1125

Registry Information
Official Title		U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Trial Start Date		2003-12-15
Registered in ClinicalTrials.gov		NCT00068367
Date Submitted to PDQ		2003-07-16
Information Last Verified		2006-01-18
NCI Grant/Contract Number		U10-CA32102

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