NCT00068367
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
PHASE2
COMPLETED
NCT00068367
INTERVENTIONAL
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
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.
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
Sarcoma
- TREATMENT
-
- Type: DRUG
- Name: erlotinib hydrochloride
- Description: 150 mg per day, daily until disease progression
- Arm Group Labels: Arm I (OSI-774)
- SWOG Cancer Research Network