S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
This study has been completed.
Sponsor:
Southwest Oncology Group
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
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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:
Detailed Description:
-
Drug: erlotinib hydrochloride
150 mg per day, daily until disease progression
Other Name: OSI-774
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
Show 101 Study LocationsSponsors 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 June 18, 2013