S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00068367

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 II

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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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:

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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012