CompletedPhase 2

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

United States24 participantsStarted 2003-12

Plain-language summary

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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cance…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.

Timeframe: 25 weeks

Trial details

NCT IDNCT00068367

SponsorSWOG Cancer Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2007-07

Results submitted2017-04-20

View on ClinicalTrials.gov More Sarcoma trials

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.