Carcinoma, Non-Small-Cell LungPhase 2NCT00294762
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
A Phase 2 study testing Tarceva, carboplatin and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by OSI Pharmaceuticals at 43 sites in 2 countries.
Trial summary
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Tarceva, carboplatin and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Jan 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >= 18
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- Radiologically measurable or evaluable disease No prior chemotherapy
- 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
- Tumor tissue block or fine needle aspirate
Who cannot join
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
- Significant cardiac disease
- Active infection
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States38 sites
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801
University of Colorado Cancer Center
Aurora, Colorado, 80045
Comprehensive Blood and Cancer Center(Part of TORI network)
Bakersfield, California, 93309
Hematology Oncology Centers of Northern Rockies Research
Billings, Montana, 59101
Fletcher Allen Health Care
Burlington, Vermont, 05401
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, 23320
Rush-Presbyterian-St.Luke's Med Ctr
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Bay Area Cancer Research Group
Concord, California, 94520
Rocky Mountain Cancer CenterResearch Department
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, 30045
Pacific Shores Medical Group
Long Beach, California, 90813-3244
UCLA Medical Center
Los Angeles, California, 90095-7077
Norton Healthcare, Inc.
Louisville, Kentucky, 40202
Central Georgia Cancer Care, P.C.
Macon, Georgia, 31201
Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
Memphis, Tennessee, 38104
The West Cancer Clinic
Memphis, Tennessee, 38120
ACORN
Memphis, Tennessee, 38138
Univ. of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Hematology-Oncology Associates, SJ, PA - Virtua Health
Mount Holly, New Jersey, 08060
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
Northridge, California, 91325
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360-2910
Alegent Healthcare
Omaha, Nebraska, 68124
MD Anderson Cancer Ctr - Orlando
Orlando, Florida, 32806
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, 91767
Providence Portland Medical Center
Portland, Oregon, 97213
Pottsville Cancer Clinic
Pottsville, Pennsylvania, 17901
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Gulfcoast Oncology Associates
Tampa, Florida, 33614
United Kingdom5 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
CR UK
Cambridge, CB2 2RE
Peterborough District Hospital
Cambridge, PE3 6DA
Beatson Oncology Centre
Glasgow, G11 6NT
Mount Vernon Hospital
Middlesex, HA6 2RN
About this study
Official title: A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Tarceva, carboplatin, paclitaxel
- Keywords
- NSCLC, Erlotinib, Tarceva, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarcevaDrug
Also called erlotinib, OSI-774
oral tablet
carboplatinDrug
IV
paclitaxelDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | 150 mg erlotinib daily Receives: Drug: Tarceva |
| Erlotinib + chemotherapy (intercalated) | Experimental | carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity Receives: Drug: Tarceva; Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression-free Survival
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Measured: 6 months after first dose
Secondary outcomes (5)
Progression-free Survival
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Measured: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
Overall Survival at 12 Months
Percentage of patients alive after 12 months of study treatment
Measured: 12 months from 1st dose
Overall Survival
Median number of months from first study treatment until time of death
Measured: From first study treatment until time of death (maximum 29.0 months)
Best Tumor Response
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Measured: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Duration of Tumor Response
Median length of time that tumor showed any type of response, ie, CR, PR, or SD
Measured: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 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
- NCT00294762
- Sponsor's protocol ID
- OSI-774-203
- Status last verified
- Aug 2012
- First submitted
- 17 Feb 2006
- Last updated
- 9 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
- ClinicalTrials.gov ID
- NCT00294762
- Acronym / sponsor ID
- OSI-774-203
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, Erlotinib, Tarceva, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Posted 14 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: Tarceva150 mg erlotinib daily |
| Erlotinib + chemotherapy (intercalated) | Experimental | Drug: Tarceva, Drug: carboplatin, Drug: paclitaxelcarboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- Radiologically measurable or evaluable disease No prior chemotherapy
- 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
Key exclusion criteria (7 listed)
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
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: erlotinib, OSI-774oral tablet | Drug | Erlotinib, Erlotinib + chemotherapy (intercalated) |
| carboplatinIV | Drug | Erlotinib + chemotherapy (intercalated) |
| paclitaxelIV | Drug | Erlotinib + chemotherapy (intercalated) |
Primary outcome
6-month Progression-free Survival
Time frame: 6 months after first dose
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
5 secondary outcomes
Progression-free Survival
Time frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
Overall Survival at 12 Months
Time frame: 12 months from 1st dose
Overall Survival
Time frame: From first study treatment until time of death (maximum 29.0 months)
Best Tumor Response
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Duration of Tumor Response
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- OSI Pharmaceuticals websiteLink provided by the sponsor.
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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.
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarceva, carboplatin and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by OSI Pharmaceuticals at 43 sites in 2 countries.
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 6 inclusion and 7 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6-month Progression-free Survival (time frame: 6 months after first dose). 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 9 Aug 2012.