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U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II


- 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

- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN

- Creatinine clearance greater than 60 mL/min


- 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


- 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


- 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


Biologic therapy

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


- More than 28 days since prior chemotherapy for this malignancy

Endocrine therapy

- Not specified


- 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


- At least 3 weeks since prior major surgery and recovered

- No prior surgical procedure affecting absorption


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response as assessed by RECIST radiographic criteria

Outcome Description:

x-rays and scans

Outcome Time Frame:

every eight weeks during treatment

Safety Issue:


Principal Investigator

Karen H. Albritton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




Start Date:

December 2003

Completion Date:

August 2009

Related Keywords:

  • Sarcoma
  • adult neurofibrosarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Nerve Sheath Neoplasms
  • Neurofibrosarcoma
  • Neurilemmoma
  • Sarcoma



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