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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00068367
First Posted: September 11, 2003
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  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: None (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:
  • Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. [ Time Frame: 25 weeks ]

    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 Outcome Measures:
  • Toxicity [ Time Frame: Up to 25 weeks ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.


Other Outcome Measures:
  • Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.
    NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY

  • Feasibility of Accruing These Patients in the Cooperative Group Setting
    NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY


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)
Arms Assigned Interventions
Experimental: Arm I (OSI-774)

Drug: erlotinib hydrochloride

Other Names:

OSI-774 150 mg per day, daily until disease progression

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068367


  Show 101 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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

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 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: April 20, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

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