Advanced Non Small Cell Lung CancerPhase 2NCT00072631
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Tarceva (Trademark) (erlotinib HCl, OSI-774) in people with Advanced Non Small Cell Lung Cancer and Failed Prior Chemotherapy, run by OSI Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy
- What is being tested?
- Tarceva (Trademark) (erlotinib HCl, OSI-774)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2003to 14 Mar 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
- Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
- Measurable disease per RECIST criteria.
- Adequate bone marrow, hepatic and renal function.
Who cannot join
- Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
- Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
- Known hypersensitivity to minocycline.
- History of serious cardiac disease that is not controlled.
- Serious eye conditions.
- Prior treatment with inhibitors of EGFR of any kind.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official title: A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.
Read the detailed description
Only patients with 0 to 1 performance status on the ECOG scale are eligible.
- Being tested
- Tarceva (Trademark) (erlotinib HCl, OSI-774)
- Keywords
- Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarceva (Trademark) (erlotinib HCl, OSI-774)Drug
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
| Study group | Role | What they receive |
|---|---|---|
| 1 erlotinib | Experimental | Not described Receives: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
Measured: 3 years
Secondary outcomes (1)
Feasibility of correlating objective response rate and duration of response to grade of rash
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2003 (estimated)
- Study start5 Nov 2003
- Primary completion14 Mar 2007
- Study completion14 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072631
- Sponsor's protocol ID
- OSI-774-202
- Other IDs
- Dose to Rash
- Status last verified
- Jun 2015
- First submitted
- 5 Nov 2003
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT00072631
- Acronym / sponsor ID
- OSI-774-202
- Keywords
- Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2003 (actual)
- Primary completion
- 14 Mar 2007 (actual)
- Study completion
- 14 Mar 2007 (actual)
- First posted
- 7 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.
Detailed description
Only patients with 0 to 1 performance status on the ECOG scale are eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 erlotinib | Experimental | Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
- Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
- Measurable disease per RECIST criteria.
- Adequate bone marrow, hepatic and renal function.
Key exclusion criteria (6 listed)
- Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
- Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
- Known hypersensitivity to minocycline.
- History of serious cardiac disease that is not controlled.
- Serious eye conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarceva (Trademark) (erlotinib HCl, OSI-774)Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash | Drug | 1 erlotinib |
Primary outcome
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
Time frame: 3 years
1 secondary outcome
Feasibility of correlating objective response rate and duration of response to grade of rash
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarceva (Trademark) (erlotinib HCl, OSI-774) in people with Advanced Non Small Cell Lung Cancer and Failed Prior Chemotherapy, run by OSI Pharmaceuticals 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Feb 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate (time frame: 3 years). 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 8 Feb 2018.