Mode
Text Size
Log in / Sign up
Phase 2 N=20 Treatment

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

Sarcoma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search