S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve S… (NCT00068367) | Clinical Trial Compass
CompletedPhase 2
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
United States24 participantsStarted 2003-12
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cance…
What they're measuring
1
Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.