Non Small Cell Lung Cancer (NSCLC)Phase 2NCT01702844
Single Arm on the Tolerability of Weekly Nab-paclitaxel
A Phase 2 study testing Nab-Paclitaxel in people with Non Small Cell Lung Cancer (NSCLC), run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC) Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Jun 2013to 12 Jul 2019
- 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
- Signed written informed consent
- Male or female patient
- Greater than or equal to 70 years of age
- Diagnosis of NSCLC histologically or cytologically confirmed
- Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or recurrence after prior surgery or radiotherapy
- Progression following one line of prior chemotherapy consisting of a platinum agent plus a standard cytotoxic partner agent other than a taxane, typically pemetrexed gemcitabine or vinorelbine
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- A single agent non cytoxic regimen if the patient has a molecular change that the non cytotoxic regimen would be expected to be efficacious for epidermal growth factor receptor (EGFR) mutation for erlotinib and (EML4) anaplastic lymphoma kinase (ALk) or ROS1 for crizotinib
- Eastern Cooperative Oncology Group performance status 0 to 2
- Adequate organ and bone marrow function as defined by
- Absolute neutrophil count greater than or equal to 1500 cells/mm3
- Creatinine less than or equal to 1.5 mg dL
- Total bilirubin less than or equal to 1.5 mg dL
- Alkaline phosphatase less than or equal to 2.5 x upper limit of normal
- Alanine aminotransferase less than or equal to 2.5 x upper limit of normal
- Aspartate aminotransferase less than or equal to 2.5 upper limit of normal
- Recovered from all reversible toxicities related to their previous treatment to less than or equal to grade 1 or baseline
- Patients must have equal to grade 2 pre existing peripheral neuropathy
- Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method as per standard of care
- Negative serum or urine bhCG pregnancy test at screening for patients of childbearing potential
- Patients with brain metastases may participate if they have undergone appropriate treatment for the lesions are at least two weeks post treatment without evidence for post treatment progression have no significant neurologic symptoms and no longer require steroids for the reason of brain metastases. Patients with symptoms suggestive of central nervous system (CNS) metastases should be evaluated with imaging prior to study participation
Who cannot join
- Prior taxane therapy for any indication
- Less than 3 weeks elapsed since prior exposure to chemotherapy
- Pre existing neuropathy greater than grade 1
- Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years localized squamous cell carcinoma of the skin basal cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies requiring locally ablative therapy only will not result in exclusion
- Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks
- Have received treatment within the last 30 days prior to study entry with any drug that has not receive regulatory approval for an indication at the time of study entry
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- Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotics symptomatic congestive heart failure unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements
- Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab paclitaxel because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study
- Known hypersensitivity to protein bound paclitaxel
- Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Bon Secours Virginia Health System
Midlothian, Virginia, 23114
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Rex Healthcare
Raleigh, North Carolina, 27607
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: LCCC 1210 - Phase II, Multicenter, Single Arm Study of the Tolerability of Weekly Nab-paclitaxel as Second Line Treatment for Elderly Patients With Advanced Lung Cancer
The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC)
Read the detailed description
This will be a non-randomized phase II study evaluating the safety and efficacy of weekly nab-paclitaxel for second-line treatment in 42 elderly patients, who are 70 years of age or greater with non-small cell lung cancer (NSLC). Patients will be required to have progressed on a single prior regimen. Nab-paclitaxel 100mg/m2 will be administered intravenously, weekly for 3 weeks of every 4-week cycle. After every two cycles of therapy, imaging will be performed to assess for response. Patients will be eligible to continue receiving therapy until the time of disease progression.
Primary Objectives To evaluate the tolerability of weekly nab-paclitaxel in older adults with advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3 weeks after discontinuation of treatment, for those who come off treatment earlier.
Secondary Objectives To estimate overall survival To estimate progression-free survival To estimate the response rate
Correlative Objectives To explore baseline components of the Geriatric Assessment (GA) as predictors of chemotherapy tolerance and overall survival To explore the use of p16 measurements in the elderly as predictors of chemotherapy tolerance and overall survival To explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by Lung Cancer Symptom Scale (LCSS) and Functional Assessment of Cancer Therapy-Lung (FACT-L).
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Nab-Paclitaxel
- Keywords
- Nab paclitaxel, Abraxane, First Line, Non small cell lung cancer, NSCLC, Phase II, Non-Randomized, Elderly, Lineberger, UNC, LCCC 1210
- 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.
Nab-PaclitaxelDrug
Also called Abraxane
Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| nab paclitaxel | Experimental | Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle Receives: Drug: Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Without Any Adverse Events Grade 3 or Higher
Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by the NCI Common Terminology Criteria for Adverse Events CTCAE, version 4. The CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)
Secondary outcomes (3)
Median Overall Survival
Overall Survival is defined as the time from day 1 (D1) of treatment until death as a result of any cause
Measured: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))
Median Progression Free Survival
Progression free survival is defined as the time from D1 of treatment until progression or death as a result of any cause. Progressive Disease (PD) is determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. PD is at least a 20% increase in the sum of the longest diameters (LD) of the target lesions taking as reference the smallest sum LD recorded since the treatment started including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of one or more new lesions also constitutes PD.
Measured: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))
Overall Response Rate
Response will be measured by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. The Overall Response rate is defined as the percentage of participants with CR or PR
Measured: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study start25 Jun 2013
- Primary completion23 Jun 2017
- Study completion12 Jul 2019
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 Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702844
- Sponsor's protocol ID
- LCCC 1210
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2012
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1210 - Phase II, Multicenter, Single Arm Study of the Tolerability of Weekly Nab-paclitaxel as Second Line Treatment for Elderly Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT01702844
- Acronym / sponsor ID
- LCCC 1210
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Keywords
- Nab paclitaxel, Abraxane, First Line, Non small cell lung cancer, NSCLC, Phase II, Non-Randomized, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 25 Jun 2013 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Posted 8 Oct 2020
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 evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC)
Detailed description
This will be a non-randomized phase II study evaluating the safety and efficacy of weekly nab-paclitaxel for second-line treatment in 42 elderly patients, who are 70 years of age or greater with non-small cell lung cancer (NSLC). Patients will be required to have progressed on a single prior regimen. Nab-paclitaxel 100mg/m2 will be administered intravenously, weekly for 3 weeks of every 4-week cycle. After every two cycles of therapy, imaging will be performed to assess for response. Patients will be eligible to continue receiving therapy until the time of disease progression.
Primary Objectives To evaluate the tolerability of weekly nab-paclitaxel in older adults with advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3 weeks after discontinuation of treatment, for those who come off treatment earlier.
Secondary Objectives To estimate overall survival To estimate progression-free survival To estimate the response rate
Correlative Objectives To explore baseline components of the Geriatric Assessment (GA) as predictors of chemotherapy tolerance and overall survival To explore the use of p16 measurements in the elderly as predictors of chemotherapy tolerance and overall survival To explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by Lung Cancer Symptom Scale (LCSS) and Functional Assessment of Cancer Therapy-Lung (FACT-L).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab paclitaxel | Experimental | Drug: Nab-PaclitaxelPatients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- Signed written informed consent
- Male or female patient
- Greater than or equal to 70 years of age
- Diagnosis of NSCLC histologically or cytologically confirmed
- Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or recurrence after prior surgery or radiotherapy
Key exclusion criteria (10 listed)
- Prior taxane therapy for any indication
- Less than 3 weeks elapsed since prior exposure to chemotherapy
- Pre existing neuropathy greater than grade 1
- Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years localized squamous cell carcinoma of the skin basal cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies requiring locally ablative therapy only will not result in exclusion
- Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks
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 |
|---|---|---|
| Nab-PaclitaxelAlso: AbraxaneAdminister 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15 | Drug | nab paclitaxel |
Primary outcome
Number of Subjects Without Any Adverse Events Grade 3 or Higher
Time frame: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)
Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by the NCI Common Terminology Criteria for Adverse Events CTCAE, version 4. The CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
3 secondary outcomes
Median Overall Survival
Time frame: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))
Median Progression Free Survival
Time frame: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))
Overall Response Rate
Time frame: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lineberger Comprehensive Cancer Center homepageLink provided by the sponsor.
- National Cancer Institute (NCI) homepageLink 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.
Jared Weiss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
8 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 Nab-Paclitaxel in people with Non Small Cell Lung Cancer (NSCLC), run by UNC Lineberger Comprehensive Cancer Center at 8 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 20 inclusion and 10 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 8 Oct 2020). 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?
Number of Subjects Without Any Adverse Events Grade 3 or Higher (time frame: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)). 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 8 Oct 2020.