Non-Small Cell Lung CancerPhase 2NCT00200395
OSI-774 (Erlotinib, Tarceva) in Elderly Patients
A Phase 2 study testing Tarceva in people with Non-Small Cell Lung Cancer, run by Montefiore Medical Center at 4 sites in United States.
Trial summary
The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Tarceva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jul 2003to 12 Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have confirmed non-small cell lung cancer. Age > 65 years Patients must have adequate organ and marrow function
Who cannot join
- Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Medical Center
New York, New York, 10003
New York University
New York, New York, 10016
Albert Einstein Cancer Center
The Bronx, New York, 10461
Montefiore Medical Center-
The Bronx, New York, 10467
About this study
Official title: Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.
Read the detailed description
In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Tarceva
- 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.
TarcevaDrug
Also called OSI-774, Erlotinib
OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.
| Study group | Role | What they receive |
|---|---|---|
| OSI-774 (Tarceva) | Experimental | Oral treatment with OSI-774 (Tarceva) will be given as a 150 mg tablets daily for 14 days. On day 15 and if there are no adverse effects the dose will be increased to 200 mg. Receives: Drug: Tarceva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented.
Measured: 1-3 years
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by CTCAE v2.0
Measured: 1-3 years
Changes in Quality of Life (QOL): questionnaire
This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.
Measured: through study completion, an average of 3 years
Rate of Progression free survival
Progression free survival is defined as the duration of time from start of treatment to time of progression.
Measured: 1-3 years
Duration of stable disease
Stable disease is measured from the start of the treatment until the criteris for progression are met., taking as reference the smallest measurements recorded since the treatment started.
Measured: 1-3 years
Overall Rate of Survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start2 Jul 2003
- Primary completion12 Jan 2007
- Study completion12 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Lakshmi Rajdev, M.D., Study chair, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200395
- Sponsor's protocol ID
- 03-01-019
- Status last verified
- Dec 2019
- First submitted
- 13 Sep 2005
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00200395
- Acronym / sponsor ID
- 03-01-019
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 2 Jul 2003 (actual)
- Primary completion
- 12 Jan 2007 (actual)
- Study completion
- 12 Jan 2007 (actual)
- First posted
- 20 Sep 2005 (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 research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.
Detailed description
In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSI-774 (Tarceva) | Experimental | Drug: TarcevaOral treatment with OSI-774 (Tarceva) will be given as a 150 mg tablets daily for 14 days. On day 15 and if there are no adverse effects the dose will be increased to 200 mg. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients must have confirmed non-small cell lung cancer. Age > 65 years Patients must have adequate organ and marrow function
Key exclusion criteria (1 listed)
- Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
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 |
|---|---|---|
| TarcevaAlso: OSI-774, ErlotinibOSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively. | Drug | OSI-774 (Tarceva) |
Primary outcome
Rate of Response
Time frame: 1-3 years
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented.
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v2.0
Time frame: 1-3 years
Changes in Quality of Life (QOL): questionnaire
Time frame: through study completion, an average of 3 years
Rate of Progression free survival
Time frame: 1-3 years
Duration of stable disease
Time frame: 1-3 years
Overall Rate of Survival
Time frame: Up to 5 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 30 Dec 2019.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Lakshmi Rajdev, M.D. study chair
Montefiore Medical Center
4 sites 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 in people with Non-Small Cell Lung Cancer, run by Montefiore Medical Center at 4 sites 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 1 inclusion and 1 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Rate of Response (time frame: 1-3 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 30 Dec 2019.