Lung CancerNCT00675597
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
A study testing Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2008to Feb 2012
- Phase
- Interventional
- 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
- Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC.
- Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below).
- Allergy to cisplatin
- Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade > or equal to 2)
- Baseline renal insufficiency (defined as a creatinine clearance of < than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
- Performance status 70% on the Karnofsky scale.
Show all 19Show fewer
- Congestive heart failure with New York Heart Association functional classification > or equal to II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
- Patient refuses to take cisplatin.
- Age > than or equal 18
- Performance Status Karnofsky > than or equal to 70%
- Peripheral neuropathy must be < than grade 1
- Hematologic (minimal values)
- Absolute neutrophil count > than or equal to 1,500/mm3
- Hemoglobin > than or equal to 8.0 g/dl
- Platelet count > than or equal to 100,000/mm3 Hepatic
- Total Bilirubin < than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Patients being considered for treatment with bevacizumab must have a urine protein: creatinine (UPC) ratio < 1.0 at screening and an MRI of brain or CT brain with IV contrast showing no evidence of brain metastases within 3 months of study entry
Who cannot join
- > 16 weeks post-op
- Prior post-operative radiation
- > 1 cycle of prior adjuvant chemotherapy
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- Women who are pregnant, or breast-feeding.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
About this study
Official title: A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.
Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.
- Conditions
- Lung Cancer
- Being tested
- Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
- Keywords
- Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), 07-178
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)Drug
Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer Receives: Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Number of Cycles
Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2012
- Study completionFeb 2012
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Christopher Azzoli, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675597
- Sponsor's protocol ID
- 07-178
- Status last verified
- Oct 2015
- First submitted
- 7 May 2008
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00675597
- Acronym / sponsor ID
- 07-178
- Conditions
- Lung Cancer
- Keywords
- Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), 07-178
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Posted 20 Nov 2015
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 whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.
Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC.
- Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below).
- Allergy to cisplatin
- Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade > or equal to 2)
- Baseline renal insufficiency (defined as a creatinine clearance of < than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
Key exclusion criteria (5 listed)
- > 16 weeks post-op
- Prior post-operative radiation
- > 1 cycle of prior adjuvant chemotherapy
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- Women who are pregnant, or breast-feeding.
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 |
|---|---|---|
| Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel. | Drug | 1 |
Primary outcome
To Measure the Number of Cycles
Time frame: 2 years
Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Christopher Azzoli, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine) in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 19 inclusion and 5 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). 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?
To Measure the Number of Cycles (time frame: 2 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 20 Nov 2015.