Phase 2
N=20
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00068367 ↗Enrolled (actual)
20
Serious AEs
60.0%
Results posted
Nov 2017
Primary outcome: Primary: Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. |
— | — |
| SECONDARY Toxicity |
1; 1; 1; 3; 1; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00068367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.