Recurrent Non-Small Cell Lung CarcinomaPhase 2NCT00602797
Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Paclitaxel, Quality-of-Life Assessment and Questionnaire Administration in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer, run by University of Nebraska at 5 sites in United States.
Trial summary
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
- What is being tested?
- Paclitaxel, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Dec 2007to 1 Aug 2014
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
- Measurable disease on imaging studies in 2 dimensions
- No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
- Patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
- Patients with other prior malignancies will be included, provided they have been disease-free for at least five years
- Patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible
Show all 18Show fewer
- Karnofsky score >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2)
- White blood cell (WBC) count >= 3,500/mm^3, OR
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelet count >= 100,000/mm^3
- Serum creatinine less than 1.5 times the upper limits of normal
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal
- Serum alkaline phosphatase less than 2.5 times the upper limits of normal
- No active serious infections or other condition precluding chemotherapy
- Non-pregnant and non-nursing
- Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
- Able to give informed consent
- Able to return for treatment and follow-up as specified in the protocol
Who cannot join
- Known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Inability to fulfill the requirements of the protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Great Plains Regional Medical Center
North Platte, Nebraska, 69103
Veterans Administration Medical Center, Omaha
Omaha, Nebraska, 68105
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105
About this study
Official title: Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES: I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine. OUTLINE: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
- Being tested
- Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration, Vinorelbine Tartrate
- 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.
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Vinorelbine TartrateDrug
Also called Biovelbin, Eunades, KW-2307, Navelbine
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vinorelbine tartrate, paclitaxel) | Experimental | Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Receives: Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vinorelbine Tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival.
Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.
Measured: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
Secondary outcomes (2)
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.
Measured: Up to week 17
Response Rate Based on RECIST Criteria
The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
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 posted28 Jan 2008 (estimated)
- Study start17 Dec 2007
- Primary completion1 Aug 2014
- Study completion1 Aug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Apar K Ganti, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602797
- Sponsor's protocol ID
- 0339-07-FB
- Other IDs
- NCI-2009-01584, P30CA036727
- Status last verified
- Sep 2023
- First submitted
- 15 Jan 2008
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Huerter MM, Meza JL, Copur MS, Tolentino A, Marr AS, Ketcham M, DeSpiegelaere H, Kruse S, Kos ME, Swenson K, Radniecki SE, Kessinger A, Ganti AK. Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. J Geriatr Oncol. 2017 Jan;8(1):18-22. doi: 10.1016/j.jgo.2016.07.006. Epub 2016 Aug 1.
PubMed 27491498
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00602797
- Acronym / sponsor ID
- 0339-07-FB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2007 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Aug 2014 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine. OUTLINE: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vinorelbine tartrate, paclitaxel) | Experimental | Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Vinorelbine TartratePatients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
- Measurable disease on imaging studies in 2 dimensions
- No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
- Patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
- Patients with other prior malignancies will be included, provided they have been disease-free for at least five years
Key exclusion criteria (3 listed)
- Known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Inability to fulfill the requirements of the protocol
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 |
|---|---|---|
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Treatment (vinorelbine tartrate, paclitaxel) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (vinorelbine tartrate, paclitaxel) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (vinorelbine tartrate, paclitaxel) |
| Vinorelbine TartrateAlso: Biovelbin, Eunades, KW-2307, NavelbineGiven IV | Drug | Treatment (vinorelbine tartrate, paclitaxel) |
Primary outcome
Progression-free Survival.
Time frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.
2 secondary outcomes
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Time frame: Up to week 17
Response Rate Based on RECIST Criteria
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27491498Huerter MM, Meza JL, Copur MS, Tolentino A, Marr AS, Ketcham M, DeSpiegelaere H, Kruse S, Kos ME, Swenson K, Radniecki SE, Kessinger A, Ganti AK. Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. J Geriatr Oncol. 2017 Jan;8(1):18-22. doi: 10.1016/j.jgo.2016.07.006. Epub 2016 Aug 1.
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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.
Apar K Ganti, MD principal investigator
University of Nebraska
5 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 Paclitaxel, Quality-of-Life Assessment and Questionnaire Administration in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer, run by University of Nebraska 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 18 inclusion and 3 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 26 Sep 2023. 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.
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 17 May 2018). 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?
Progression-free Survival. (time frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years). 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 NCT00602797, which also lists 1 linked publication.
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 26 Sep 2023.