AzTrials
AzTrials

Lung CancerPhase 1NCT00738335

Stereotactic Radiosurgery and Erlotinib in Treating Patients With Non-Small Cell Lung Cancer and Brain Metastases

A Phase 1 study testing erlotinib hydrochloride, immunoenzyme technique and laboratory biomarker analysis in people with Lung Cancer and Metastatic Cancer, run by University of California, San Francisco at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Metastatic Cancer
What is being tested?
erlotinib hydrochloride, immunoenzyme technique and laboratory biomarker analysis
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2009to Jul 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
  • Fewer than 5 intraparenchymal brain metastases by gadolinium-enhanced MRI meeting the following criteria:
  • Maximum diameter ≤ 4.0 cm
  • If multiple lesions are present and one lesion is > 3.0 cm, the remaining lesions must be ≤ 3.0 cm in maximum diameter
  • No metastases within 3 mm of the optic nerve or optic chiasm such that some portion of the optic nerve or chiasm would receive > 9 Gy from radiosurgery
  • No metastases in the brainstem, midbrain, pons, or medulla
  • No prior complete resection of a single brain metastasis or of all known brain metastases
  • Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
  • No clinical or radiographic evidence of unstable systemic progression (other than the study lesion[s]) within the past month
  • Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
  • Isolated brain metastases with stable systemic disease allowed
  • No leptomeningeal metastases by MRI and/or positive cerebrospinal fluid cytology

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • ANC > 1,000/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 10 g/dL
  • PT and PTT normal
  • AST < 2 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2 times ULN
  • Total bilirubin < 2 times ULN
  • Lactic dehydrogenase < 2 times ULN
  • Serum creatinine < 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy
  • Neurologic function status 0-2
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride
  • No contraindication to MRI (e.g., cardiac pacemaker)
  • No absolute contraindication to lumbar puncture

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior systemic therapy allowed
  • No prior cranial radiotherapy
  • Prior radiotherapy to noncranial sites allowed
  • More than 1 week since prior intrathecal chemotherapy or prior treatment of leptomeningeal carcinoma
  • No concurrent systemic therapy
  • Prior or current erlotinib hydrochloride for treatment of systemic disease allowed provided systemic disease has not progressed while on erlotinib hydrochloride
  • No concurrent enzyme-inducing anticonvulsant
  • If patients are on an enzyme-inducing anticonvulsant (e.g., phenytoin, carbamazepine, or phenobarbital), the agent must be converted to a nonenzyme-inducing anticonvulsant before or at the start of erlotinib hydrochloride treatment
  • No concurrent CYP3A4 inhibitors or inducers (e.g., Hypericum perforatum [St. John wort] or ketoconazole)
  • No other concurrent investigational therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase I Open-Label, Dose-Finding Study to Evaluate the Safety and Efficacy of Concurrent Radiosurgery and Erlotinib Administration in Non-Small Cell Lung Cancer Patients With Brain Metastases

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with stereotactic radiosurgery may kill more tumor cells.

PURPOSE: This phase I clinical trial is studying the side effects of erlotinib when given together with stereotactic radiosurgery and to see how well it works in treating patients with non-small cell lung cancer with brain metastases.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the acute as well as long-term toxicity (especially grade III neurotoxicity) of concurrent erlotinib hydrochloride and single-fraction radiosurgery in patients with non-small cell lung cancer (NSCLC) and brain metastases.

Secondary

  • To determine the freedom from progression in all detected lesions (i.e., radiosurgically treated and untreated) and the rate of response of radiosurgically treated lesions in patients receiving concurrent erlotinib hydrochloride and radiosurgery as compared with historical controls treated with gamma knife radiosurgery alone at UCSF.
  • To measure the rate of freedom from any CNS progression in these patients at 1 year post treatment.
  • To assess cerebrospinal fluid (CSF) distribution of erlotinib hydrochloride by measuring both erlotinib hydrochloride and its major metabolite, OSI-420, in plasma and CSF at 4 or more days after initial erlotinib hydrochloride administration but before radiosurgery, and again at 4 weeks after stereotactic radiosurgery (optional).
  • To perform CSF and serum biomarker analysis for NSCLC using 2-dimensional liquid chromatography or mass spectrometry (2D-LC/MS).
  • To determine the incidence of subclinical leptomeningeal disease in patients assigned to gamma-knife treatment and who do not exhibit signs or symptoms or carcinomatous meningitis.

OUTLINE: Patients receive oral erlotinib hydrochloride once daily for at least 7 days. Patients then undergo stereotactic radiosurgery on day 0. Beginning the day after radiosurgery, patients receive erlotinib hydrochloride once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients may continue to receive erlotinib hydrochloride at the discretion of their oncologist.

Patients undergo cerebrospinal fluid (CSF) and blood sample collection at baseline (at least 4 days after starting erlotinib hydrochloride and prior to radiosurgery) for pharmacokinetic and biomarker correlative studies. Samples are analyzed for concentrations of erlotinib hydrochloride by 2-dimensional-liquid chromatography/mass spectrometry and antithrombin by enzyme-linked immunosorbent assay.

After completion of study therapy, patients are followed every 3 months for 1 year.

Being tested
erlotinib hydrochloride, immunoenzyme technique, laboratory biomarker analysis, liquid chromatography, mass spectrometry
Keywords
stage IV non-small cell lung cancer, tumors metastatic to brain, recurrent non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib hydrochlorideDrug

  • immunoenzyme techniqueOther

  • laboratory biomarker analysisOther

  • liquid chromatographyOther

  • mass spectrometryOther

  • pharmacological studyOther

  • stereotactic radiosurgeryRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute and long-term toxicity (i.e., neurotoxicity, gastrointestinal, cutaneous, and hematologic) as assessed by NCI CTCAE v3.0.

Secondary outcomes (6)
  1. Disease progression

  2. Response rate of radiosurgically treated lesions in patients receiving concurrent erlotinib hydrochloride and radiosurgery on this study vs the response rate of historical controls previously treated with gamma knife radiosurgery alone

  3. CNS progression at 1 year

  4. Distribution of erlotinib hydrochloride in plasma and cerebrospinal fluid (CSF)

  5. CSF and serum biomarkers

  6. Incidence of subclinical leptomeningeal disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738335
Sponsor's protocol ID
CDR0000612064
Other IDs
UCSF-072520, CC# 072520, GENENTECH-UCSF-072520
Status last verified
Oct 2012
First submitted
19 Aug 2008
Last updated
4 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing erlotinib hydrochloride, immunoenzyme technique and laboratory biomarker analysis in people with Lung Cancer and Metastatic Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute and long-term toxicity (i.e., neurotoxicity, gastrointestinal, cutaneous, and hematologic) as assessed by NCI CTCAE v3.0.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in