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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

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