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Trial record 62 of 109 for:    "Schwannoma"

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

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ClinicalTrials.gov Identifier: NCT00068367
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Intervention Drug: erlotinib hydrochloride
Enrollment 24

Recruitment Details  
Pre-assignment Details Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description OSI-774 150 mg daily for 25 weeks
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description OSI-774 150 mg daily for 25 weeks
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
45.3
(19.8 to 76.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
16
  80.0%
Unknown or Not Reported
2
  10.0%
Prior multi-agent chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Yes
14
  70.0%
No
6
  30.0%
1.Primary Outcome
Title Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
Hide Description

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.

Time Frame 25 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description:
OSI-774 150 mg daily for 25 weeks
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Toxicity
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 25 weeks
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Hide Analysis Population Description
All participants receiving at least some protocol treatment
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description:
OSI-774 150 mg daily for 25 weeks
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Anorexia 1
Diarrhea 1
Dyspnea (shortness of breath) 1
Fatigue (asthenia, lethargy, malaise) 3
Hemoglobin 1
Nausea 1
Pain - Abdomen NOS 1
Pruritus/itching 1
Rash/desquamation 1
Somnolence/depressed level of consciousness 1
Vision-blurred vision 1
3.Other Pre-specified Outcome
Title Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.
Hide Description NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
Time Frame [Not Specified]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description:
OSI-774 150 mg daily for 25 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Feasibility of Accruing These Patients in the Cooperative Group Setting
Hide Description NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
Time Frame [Not Specified]
Outcome Measure Data Not Reported
Time Frame Up to 25 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (OSI-774)
Hide Arm/Group Description OSI-774 150 mg daily for 25 weeks
All-Cause Mortality
Arm I (OSI-774)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (OSI-774)
Affected / at Risk (%)
Total   12/20 (60.00%) 
Gastrointestinal disorders   
Diarrhea  1  1/20 (5.00%) 
Pain - Abdomen NOS  1  1/20 (5.00%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/20 (5.00%) 
Pain - Chest/thorax NOS  1  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders   
Pain - Back  1  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  9/20 (45.00%) 
Nervous system disorders   
Pain - Neuralgia/peripheral nerve  1  1/20 (5.00%) 
Syncope (fainting)  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  2/20 (10.00%) 
Hypoxia  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (OSI-774)
Affected / at Risk (%)
Total   19/20 (95.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  2/20 (10.00%) 
Eye disorders   
Dry eye syndrome  1  1/20 (5.00%) 
Ocular/Visual-Other  1  2/20 (10.00%) 
Vision-blurred vision  1  1/20 (5.00%) 
Gastrointestinal disorders   
Constipation  1  1/20 (5.00%) 
Diarrhea  1  7/20 (35.00%) 
Dry mouth/salivary gland (xerostomia)  1  1/20 (5.00%) 
Hemorrhage, GI - Oral cavity  1  1/20 (5.00%) 
Hemorrhage, GI - Upper GI NOS  1  1/20 (5.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  2/20 (10.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  1/20 (5.00%) 
Nausea  1  6/20 (30.00%) 
Pain - Abdomen NOS  1  2/20 (10.00%) 
Vomiting  1  4/20 (20.00%) 
General disorders   
Death not associated with CTCAE term - Death NOS  1  1/20 (5.00%) 
Edema: head and neck  1  1/20 (5.00%) 
Edema: limb  1  2/20 (10.00%) 
Fatigue (asthenia, lethargy, malaise)  1  9/20 (45.00%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  2/20 (10.00%) 
Pain - Chest/thorax NOS  1  1/20 (5.00%) 
Pain-Other  1  1/20 (5.00%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus  1  1/20 (5.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  1/20 (5.00%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/20 (5.00%) 
Alkaline phosphatase  1  1/20 (5.00%) 
Bilirubin (hyperbilirubinemia)  1  2/20 (10.00%) 
Leukocytes (total WBC)  1  1/20 (5.00%) 
Lymphopenia  1  2/20 (10.00%) 
Weight loss  1  2/20 (10.00%) 
Metabolism and nutrition disorders   
Anorexia  1  7/20 (35.00%) 
Calcium, serum-low (hypocalcemia)  1  1/20 (5.00%) 
Dehydration  1  1/20 (5.00%) 
Glucose, serum-high (hyperglycemia)  1  1/20 (5.00%) 
Glucose, serum-low (hypoglycemia)  1  1/20 (5.00%) 
Potassium, serum-low (hypokalemia)  1  2/20 (10.00%) 
Sodium, serum-high (hypernatremia)  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Pain - Back  1  3/20 (15.00%) 
Pain - Chest wall  1  1/20 (5.00%) 
Pain - Extremity-limb  1  1/20 (5.00%) 
Pain - Muscle  1  1/20 (5.00%) 
Pain - Neck  1  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  6/20 (30.00%) 
Nervous system disorders   
Dizziness  1  1/20 (5.00%) 
Leak, cerebrospinal fluid (CSF)  1  1/20 (5.00%) 
Neuropathy: sensory  1  1/20 (5.00%) 
Ocular/Visual-Other  1  2/20 (10.00%) 
Pain - Head/headache  1  4/20 (20.00%) 
Pain - Neuralgia/peripheral nerve  1  1/20 (5.00%) 
Somnolence/depressed level of consciousness  1  1/20 (5.00%) 
Psychiatric disorders   
Confusion  1  1/20 (5.00%) 
Mood alteration - depression  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/20 (5.00%) 
Cough  1  6/20 (30.00%) 
Dyspnea (shortness of breath)  1  8/20 (40.00%) 
Pulmonary hypertension  1  1/20 (5.00%) 
Pulmonary/Upper Respiratory-Other  1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  4/20 (20.00%) 
Hair loss/Alopecia (scalp or body)  1  4/20 (20.00%) 
Pruritus/itching  1  3/20 (15.00%) 
Rash/desquamation  1  16/20 (80.00%) 
Skin breakdown/decubitus ulcer  1  1/20 (5.00%) 
Vascular disorders   
Hemorrhage/Bleeding-Other  1  2/20 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Publications of Results:
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