Non-small Cell Lung CancerPhase 2NCT00165334
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
A Phase 2 study testing Cetuximab and Vinorelbine (Navelbine) in people with Non-small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Cetuximab and Vinorelbine (Navelbine)
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2005to Nov 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years of age or greater
- Stage IV or IIIB Non-small cell lung cancer
- Must at least be able to walk and capable of taking care of yourself although unable to carry out work activities
- 3 or more weeks since completing prior radiotherapy
- 3 or more weeks since prior major surgery
- Blood tests that show your kidneys, liver and bone marrow to be working adequately
- Life expectancy of 8 weeks or more
Who cannot join
- Prior anticancer therapy within the past 3 years, including chemotherapy
- Other currently active cancer
- Uncontrolled Central Nervous System (CNS) problems
- Pre-existing disease or abnormality of the nervous system
- Hepatitis or Known HIV
- Active uncontrolled infection
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- Incomplete healing from previous major surgery
- Significant history of uncontrolled cardiac disease such as high blood pressure, recent heart attack (within past 6 months), congestive heart failure, etc.
- Prior therapy which targets the ErbB pathway
- Prior severe infusion reaction to an antibody
- Chemotherapy or other investigational agent not indicated in the study protocol occuring at the same time as this study treatment
- A medical condition that could make it unsafe for you to participate in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.
Read the detailed description
- Each cycle of study treatment is 21 days long. Cetuximab will be administered weekly intravenously on days 1, 8 and 15 of the 21-day cycle.
- Vinorelbine will be administered intravenously on days 1 and 8 of the 21-day cycle. On the days when the patient receives both cetuximab and vinorelbine, cetuximab will be given first.
- For the first cycle only, the first infusion of cetuximab will be in a larger dose and over a two-hour period of time. Beginning with the second treatment of cetuximab, the patient will receive a smaller dose over a one-hour period of time.
- For the first treatment of cetuximab, the patient will have their blood pressure, temperature, breathing rate and heart rate (vital signs) taken at the following time points: before the infusion, 1/2 hour into the infusion, at the end of infusion, and one hour after the infusion.
- For each subsequent cetuximab treatment, vital signs will be taken before each infusion and one hour after the end of infusion. The patient will be required to remain in the infusion room for one hour after the end of each cetuximab treatment for observation.
- CT scan(s), MRI(s), and/or x-rays(s) of the site(s) of cancer will be done every six weeks (every two cycles) while the patient is on the study to assess the extent of the cancer and the response to treatment.
- The duration of active participation in this study will depend on how the patients non-small cell lung cancer responds to treatment and how well they tolerate the treatment. The patient may receive up to six cycles of treatment with vinorelbine and cetuximab. After these six cycles the patient may continue on cetuximab alone as long as they are tolerating the drug and the cancer doesn't progress.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cetuximab, Vinorelbine (Navelbine)
- Keywords
- Non-small cell lung cancer, Cetuximab, Vinorelbine, Navelbine, Previously untreated lung cancer
- 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.
CetuximabDrug
Vinorelbine (Navelbine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
Secondary outcomes (2)
To determine the safety of cetuximab plus vinorelbine in patients 70 years or older
to determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Bristol-Myers Squibb
- Investigators
- Pasi A Janne, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165334
- Sponsor's protocol ID
- 04-422
- Status last verified
- Jul 2009
- First submitted
- 9 Sep 2005
- Last updated
- 22 Jul 2009
- Results posted
- No
Publications
Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72. doi: 10.1093/jnci/95.5.362.
PubMed 12618501Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst. 1999 Jan 6;91(1):66-72. doi: 10.1093/jnci/91.1.66.
PubMed 9890172
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT00165334
- Acronym / sponsor ID
- 04-422
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Cetuximab, Vinorelbine, Navelbine, Previously untreated lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Bristol-Myers Squibb
- Study start
- Jun 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 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 study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.
Detailed description
- Each cycle of study treatment is 21 days long. Cetuximab will be administered weekly intravenously on days 1, 8 and 15 of the 21-day cycle.
- Vinorelbine will be administered intravenously on days 1 and 8 of the 21-day cycle. On the days when the patient receives both cetuximab and vinorelbine, cetuximab will be given first.
- For the first cycle only, the first infusion of cetuximab will be in a larger dose and over a two-hour period of time. Beginning with the second treatment of cetuximab, the patient will receive a smaller dose over a one-hour period of time.
- For the first treatment of cetuximab, the patient will have their blood pressure, temperature, breathing rate and heart rate (vital signs) taken at the following time points: before the infusion, 1/2 hour into the infusion, at the end of infusion, and one hour after the infusion.
- For each subsequent cetuximab treatment, vital signs will be taken before each infusion and one hour after the end of infusion. The patient will be required to remain in the infusion room for one hour after the end of each cetuximab treatment for observation.
- CT scan(s), MRI(s), and/or x-rays(s) of the site(s) of cancer will be done every six weeks (every two cycles) while the patient is on the study to assess the extent of the cancer and the response to treatment.
- The duration of active participation in this study will depend on how the patients non-small cell lung cancer responds to treatment and how well they tolerate the treatment. The patient may receive up to six cycles of treatment with vinorelbine and cetuximab. After these six cycles the patient may continue on cetuximab alone as long as they are tolerating the drug and the cancer doesn't progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 70 years of age or greater
- Stage IV or IIIB Non-small cell lung cancer
- Must at least be able to walk and capable of taking care of yourself although unable to carry out work activities
- 3 or more weeks since completing prior radiotherapy
- 3 or more weeks since prior major surgery
Key exclusion criteria (12 listed)
- Prior anticancer therapy within the past 3 years, including chemotherapy
- Other currently active cancer
- Uncontrolled Central Nervous System (CNS) problems
- Pre-existing disease or abnormality of the nervous system
- Hepatitis or Known HIV
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 |
|---|---|---|
| Cetuximab | Drug | – |
| Vinorelbine (Navelbine) | Drug | – |
Primary outcome
To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
2 secondary outcomes
To determine the safety of cetuximab plus vinorelbine in patients 70 years or older
to determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine.
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 22 Jul 2009.
- Background: PubMed 12618501Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72. doi: 10.1093/jnci/95.5.362.
- Background: PubMed 9890172Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst. 1999 Jan 6;91(1):66-72. doi: 10.1093/jnci/91.1.66.
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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.
Pasi A Janne, MD, PhD principal investigator
Dana-Farber Cancer Institute
3 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 Cetuximab and Vinorelbine (Navelbine) in people with Non-small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 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 7 inclusion and 12 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 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00165334, which also lists 2 linked publications.
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 22 Jul 2009.