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AzTrials

Non-small Cell Lung CancerPhase 2NCT02405910

Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.

A Phase 2 study testing Nab-paclitaxel and Gemcitabine in people with Non-small Cell Lung Cancer, run by West Virginia University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Nab-paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Mar 2015to Apr 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically proven newly diagnosed stage IV or stage IIIB non-squamous Non-small Cell Lung Cancer (NSCLC) - Recurrent advanced NSCLC will be allowed if they have never received chemotherapy for metastatic disease. - Prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Washout period of 4 weeks for chemo/radiation/experimental agents
  • Resolution of all toxicities to < grade 2 prior to starting treatment (excluding alopecia)
  • Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Show all 9Show fewer
  • Adequate hepatic, renal, and bone marrow functions
  • Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
  • Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential

Who cannot join

  • Patient with New York Heart Association class III or IV heart failure
  • Women of child bearing potential (WOCBP) are not currently pregnant or breast-feeding
  • Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
  • Previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
  • Grade ≥2 peripheral neuropathy at baseline assessment from any cause
  • Symptomatic brain metastases will be excluded. Treated Brain metastases will be allowed that are neurologically stable.
  • Patients with adenocarcinoma with activating EGFR mutation (exon 19 deletions / insertions, exon 21 point mutations) or EML4-ALK translocation are excluded unless they are ineligible for epidermal growth factor receptor (EGFR) or ALK targeting agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • West Virginia University Hospitals - Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

Other trials in United States

About this study

Official title: A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC).

Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).

Read the detailed description

This study is designed determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine at two different dose combinations in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC). Two dosing strategies of the nab-paclitaxel plus gemcitabine combination will be compared for efficacy and tolerability. One arm will combine both agents at their current Food and Drug Administration (FDA) approved doses for the indication of non-small cell lung cancer (NSCLC). This arm will utilize gemcitabine 1250 mg/m2 IV day 1 and day 8 (FDA approved dose in combination with cisplatin) combined with nab-paclitaxel 100 mg/m2 IV day 1, 8 and 15 every 21 days (FDA approved dose in combination with carboplatin). The second arm will utilize the drugs at doses that are approved by the FDA when combined with one another in metastatic pancreatic adenocarcinoma. This arm will consist of gemcitabine 1000 mg/m2 IV day 1, 8 and 15 combined with nab-paclitaxel at 125 mg/m2 IV day 1, 8 and 15 every 28 days. Patients will be randomized equally to the two treatment arms. Primary objective is to assess progression-free survival (PFS). Toxicity assessment, response and overall survival are secondary endpoints. Statistical power is based on the comparison to historical control within each treatment arm. In particular, a sample size of 23 patients in each arm will have 84% power to differentiate the 3-month PFS of 30% (null hypothesis) versus 60% (alternative) based on a 2-sided test at a significance level of 0.05. There will be a lead-in phase to this trial for each treatment arm with a cohort size of 3 and a maximum of 6 patients.

Keywords
advanced, non-squamous, first line therapy
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.

Study groups in NCT02405910
Study groupRoleWhat they receive
A - Nab-paclitaxel 100mg + Gemcitabine 1250mgExperimentalNab-paclitaxel 100 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 21 day cycle. On days 1 and 8 of each cycle, nab-paclitaxel administration will be followed by the administration of gemcitabine 1250 mg/m2 as a 30 minute infusion (maximum 40 minutes).
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine
B - Nab-paclitaxel 125mg + Gemcitabine 1000mgExperimentalNab-paclitaxel 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 28 day cycle. Each nab-paclitaxel administration will be followed by the administration of gemcitabine 1000 mg/m2 as a 30 minute infusion (maximum 40 minutes) on days 1, 8 and 15. Treatments will be repeated until progression or intolerance.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    To assess the progression-free survival (PFS) on patients with nab-paclitaxel and Gemcitabine at two different dose combinations and to compare the PFS to the historical data

    Measured: From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Secondary outcomes (1)

  1. To explore differences in progression free survival (PFS) between two dose combinations of nab-paclitaxel with Gemcitabine in patients with advanced NSCLC.

    Measured: From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2015 (estimated)
  2. Study start15 Mar 2015 (estimated)
  3. Primary completionDec 2017 (estimated)
  4. Study completionApr 2023 (estimated)

Why it stopped: PI Left Institution

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405910
Sponsor's protocol ID
WVU020514
Status last verified
Oct 2017
First submitted
24 Mar 2015
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • D'Addario G, Pintilie M, Leighl NB, Feld R, Cerny T, Shepherd FA. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005 May 1;23(13):2926-36. doi: 10.1200/JCO.2005.03.045. Epub 2005 Feb 22.

    PubMed 15728229

  • Jiang J, Liang X, Zhou X, Huang R, Chu Z, Zhan Q. Non-platinum doublets were as effective as platinum-based doublets for chemotherapy-naive advanced non-small-cell lung cancer in the era of third-generation agents. J Cancer Res Clin Oncol. 2013 Jan;139(1):25-38. doi: 10.1007/s00432-012-1294-z. Epub 2012 Aug 5.

    PubMed 22864816

  • Davidoff AJ, Tang M, Seal B, Edelman MJ. Chemotherapy and survival benefit in elderly patients with advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2191-7. doi: 10.1200/JCO.2009.25.4052. Epub 2010 Mar 29.

    PubMed 20351329

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel and Gemcitabine in people with Non-small Cell Lung Cancer, run by West Virginia University at 1 site 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.

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: From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.). 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 NCT02405910, which also lists 3 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 6 Nov 2017.

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