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

September 10, 2003
January 13, 2012
December 2003
July 2007   (final data collection date for primary outcome measure)
Tumor response as assessed by RECIST radiographic criteria [ Time Frame: every eight weeks during treatment ] [ Designated as safety issue: No ]
x-rays and scans
Not Provided
Complete list of historical versions of study NCT00068367 on ClinicalTrials.gov Archive Site
Toxicity as assessed by CTCAE [ Time Frame: every two weeks for two cycles and then every four weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: erlotinib hydrochloride
150 mg per day, daily until disease progression
Other Name: OSI-774
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2009
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068367
CDR0000322023, S0330, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
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
Southwest Oncology Group
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP