Clinical trial · Interventional
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
NCT00068367CI-TRIAL-00030210completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I (OSI-774)
- description
- Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression
- interventionNames
- Drug: erlotinib hydrochloride
Primary outcomes (1)
- measure
- Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
- timeFrame
- 25 weeks
- description
- Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAlbritton KH, Rankin C, Coffin CM, et al.: Phase II study of erlotinib in metastatic or unresectable malignant peripheral nerve sheath tumors (MPNST). [Abstract] J Clin Oncol 24 (Suppl 18): A-9518, 524s, 2006.