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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00068367
First received: September 10, 2003
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Tumor response as assessed by RECIST radiographic criteria [ Time Frame: every eight weeks during treatment ] [ Designated as safety issue: No ]
    x-rays and scans


Secondary Outcome Measures:
  • Toxicity as assessed by CTCAE [ Time Frame: every two weeks for two cycles and then every four weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: December 2003
Study Completion Date: August 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: erlotinib hydrochloride
    150 mg per day, daily until disease progression
    Other Name: OSI-774
Detailed Description:

OBJECTIVES:

  • Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function (e.g., expression, phosphorylation, or markers of signal transduction downstream of EGFR) with response and progression-free and overall survival in patients treated with this drug.
  • Determine the feasibility of accruing these patients in the cooperative group setting.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068367

  Show 101 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Karen H. Albritton, MD Dana-Farber Cancer Institute
Study Chair: R. Lor Randall, MD, FACS University of Utah
Study Chair: Scott M. Schuetze, MD, PhD University of Michigan Cancer Center
  More Information

Additional Information:
Publications:
Albritton 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.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00068367     History of Changes
Other Study ID Numbers: CDR0000322023, S0330, U10CA032102
Study First Received: September 10, 2003
Last Updated: January 13, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
adult neurofibrosarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Nerve Sheath Neoplasms
Neurofibrosarcoma
Neurilemmoma
Sarcoma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neurofibroma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014