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

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00068367

S0330 (Other Identifier)

CDR0000322023

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Arm I (OSI-774)

Experimental group

Description:

Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression

Treatment:

Drug: erlotinib hydrochloride