Trial · NCT00068367
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
NCT00068367, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor. Trials, record NCT00068367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
- NCT number
- NCT00068367
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Sarcoma
- Interventions
- erlotinib hydrochloride
- First posted
- 2003-09-11
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | 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 | Toxicity | Up to 25 weeks | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Other | 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 | |
| Other | Feasibility of Accruing These Patients in the Cooperative Group Setting | NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | 25 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Toxicity | Up to 25 weeks | All participants receiving at least some protocol treatment | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug. | ||||
| OTHER_PRE_SPECIFIED | Feasibility of Accruing These Patients in the Cooperative Group Setting |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | Arm I (OSI-774) | 0 | Participants | ||
| Toxicity | Arm I (OSI-774) | Anorexia | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Diarrhea | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Dyspnea (shortness of breath) | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Fatigue (asthenia, lethargy, malaise) | 3 | Participants | |
| Toxicity | Arm I (OSI-774) | Hemoglobin | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Nausea | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Pain - Abdomen NOS | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Pruritus/itching | 1 | Participants | |
| Toxicity | Arm I (OSI-774) | Rash/desquamation | 1 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (OSI-774) | 20 | |
| Overall Study | COMPLETED | Arm I (OSI-774) | 20 | |
| Overall Study | NOT COMPLETED | Arm I (OSI-774) | 0 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | Arm I (OSI-774) | 2 | 20 | |
| other | Dry eye syndrome | Eye disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Ocular/Visual-Other | Eye disorders | Arm I (OSI-774) | 2 | 20 | |
| other | Vision-blurred vision | Eye disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Constipation | Gastrointestinal disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I (OSI-774) | 7 | 20 | |
| other | Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Hemorrhage, GI - Oral cavity | Gastrointestinal disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Hemorrhage, GI - Upper GI NOS | Gastrointestinal disorders | Arm I (OSI-774) | 1 | 20 | |
| other | Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | Arm I (OSI-774) | 2 | 20 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (OSI-774) | ||
| Total, other adverse events | Arm I (OSI-774) | 19 | 20 |
| Total, serious adverse events | Arm I (OSI-774) | 12 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00068367
GET https://conductscience.org/api/trials/v1/NCT00068367/events?page=2