AzTrials
AzTrials

Non-Small Cell Lung CarcinomaPhase 3NCT00540514

Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer

A Phase 3 study testing Albumin-bound paclitaxel, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Carcinoma, run by Celgene at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced 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 Carcinoma
What is being tested?
Albumin-bound paclitaxel, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,052 participants
Where
37 sitesin 2 countries
Study dates
1 Nov 2007to 1 Feb 2013
Phase
Phase 3
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

  • Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
  • Male or non-pregnant and non-lactating female, and equal or greater than age 18
  • If a female patient is of child-bearing potential, as evidence by regular menstrual periods, she must have a negative serum pregnancy test (beta human chorionic gonadotropin [βhCG]) documented within 72 hours of the first administration of study drug
  • If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator
  • No other current active malignancy
  • Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion)
Show all 18Show fewer
  • Patients must have received no prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
  • Patient has the following blood counts at baseline:
  • Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L
  • Platelets greater than or equal to 100x10^9/L
  • Hemoglobin (Hgb) greater than or equal to 9 g/dL
  • Patient has the following blood chemistry levels at baseline:
  • Aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT) less than or equal to 2.5 x upper limit of normal range (ULN) or less than or equal to 5.0 x ULN if liver metastases;
  • Total bilirubin less than or equal to ULN
  • Creatinine less than or equal to 1.5 mg/dL
  • Expected survival of greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities

Who cannot join

  • Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable and off therapy for greater than or equal to 1 month
  • The only evidence of disease is non-measurable
  • Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events [CTCAE] Version 3).
  • Patient received radiotherapy in the last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
  • Patient has a clinically significant concurrent illness
  • Patient has received treatment with any investigational drug within the previous 4 weeks
Show all 9Show fewer
  • Patient has a history of allergy or hypersensitivity to any of the study drugs
  • Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
  • Patient is enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States31 sites

  • Cancer Outreach Associates, PC

    Abingdon, Virginia, 24211

  • Phoebe Cancer Center

    Albany, Georgia, 31701

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Essex Oncology of North Jersey

    Belleville, New Jersey, 07109

  • Fletcher Allen Health Care

    Burlington, Vermont, 05405

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Dallas Oncology Consultants, PA

    Duncanville, Texas, 75137

  • Southwest Cancer Care

    Escondido, California, 92064

  • The Center for Cancers and Blood Disorders

    Fort Worth, Texas, 76104

  • Robert A. Moss, MD, FACP, Inc.

    Fountain Valley, California, 92708

  • Genesis Cancer Center- Hot Springs

    Hot Springs, Arkansas, 71913

  • Clearview Cancer Institute Oncology Specialties, P.C.

    Huntsville, Alabama, 35805

  • St. Mary Medical Center- Oncology, Hematology PC

    Langhorne, Pennsylvania, 19047

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas, 72205

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Kentuckiana Cancer Institute, PLLC

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Comprehensice Cancer Ctr.

    Palms Springs, California, 92262

  • Mercy Hospital

    Portland, Maine, 04101

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • St. Louis University

    St Louis, Missouri, 63110

  • Gulf Coast Oncology Associates

    St. Petersburg, Florida, 33705

  • Lake County Oncology and Hematology, PA

    Tavares, Florida, 32778

  • Blood and Cancer Center of East Texas

    Tyler, Texas, 75701

  • Tyler Hematology Oncology

    Tyler, Texas, 75701

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Canada6 sites

  • William Osler Health Centre, Brampton Clinic

    Brampton, Ontario, L6R 3J7

  • McGill University- Dept. of Oncology

    Montreal, Quebec, H2W 1S6

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W4

  • Toronto East General Hospital

    Toronto, Ontario, M4C3E7

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).

Being tested
Albumin-bound paclitaxel, Paclitaxel, Carboplatin
Keywords
Advanced Non-Small Cell 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.

  • Albumin-bound paclitaxelDrug

    Also called ABI-007, ABRAXANE®, nab®-paclitaxel

    Administered by intravenous infusion.

  • PaclitaxelDrug

    Also called Taxol®

    Administered by intravenous infusion.

  • CarboplatinDrug

    Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate [GFR] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).

Study groups in NCT00540514
Study groupRoleWhat they receive
Albumin-bound paclitaxel + CarboplatinExperimentalParticipants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
Receives: Drug: Albumin-bound paclitaxel; Drug: Carboplatin
Paclitaxel + CarboplatinActive comparatorParticipants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment

    Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.

    A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.

    Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).

    Measured: Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.

Secondary outcomes (7)

  1. Progression-free Survival by Blinded Radiology Assessment

    Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesion(s).

    Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free.

    Measured: Assessed every 6 weeks until progression or death, up to 38 months

  2. Overall Participant Survival

    Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.

    Measured: Up to 38 months

  3. Percentage of Participants With Controlled Disease

    Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.

    Measured: Assessed every 6 weeks, up to 22 months

  4. Duration of Response in Responding Patients

    Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.

    Measured: Assessed every 6 weeks, up to 38 months

  5. Number of Participants With Adverse Events (AEs)

    A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

    Measured: Up to 38 months

  6. Pharmacokinetic (PK) Parameters

    Measured: Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.

  7. SPARC Status and Correlation With Overall Survival

    The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels.

    To classify participants into "high-SPARC" and "low-SPARC" groups, an average z-score was calculated across variables and classified "high-SPARC" (average z-scores ≥0) and "low-SPARC" (average z-scores <0) groups.

    SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause).

    Measured: Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.

Timeline

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

  1. First posted8 Oct 2007 (estimated)
  2. Study start1 Nov 2007
  3. Primary completion1 Oct 2009
  4. Study completion1 Feb 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,052 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00540514
Sponsor's protocol ID
CA031
Status last verified
Oct 2019
First submitted
4 Oct 2007
Last updated
29 Oct 2019
Data monitoring committee
Yes

Publications

  • Hirsh V. nab-paclitaxel for the management of patients with advanced non-small-cell lung cancer. Expert Rev Anticancer Ther. 2014 Feb;14(2):129-41. doi: 10.1586/14737140.2014.881719.

    PubMed 24467217

  • Langer CJ, Hirsh V, Ko A, Renschler MF, Socinski MA. Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: analysis of safety and efficacy in patients with renal impairment. Clin Lung Cancer. 2015 Mar;16(2):112-20. doi: 10.1016/j.cllc.2014.09.003. Epub 2014 Sep 30.

    PubMed 25572008

  • Langer CJ, Hirsh V, Okamoto I, Lin FJ, Wan Y, Whiting S, Ong TJ, Renschler MF, Botteman MF. Survival, quality-adjusted survival, and other clinical end points in older advanced non-small-cell lung cancer patients treated with albumin-bound paclitaxel. Br J Cancer. 2015 Jun 30;113(1):20-9. doi: 10.1038/bjc.2015.181. Epub 2015 Jun 2.

    PubMed 26035702

  • Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.

    PubMed 22547591

  • Socinski MA, Langer CJ, Okamoto I, Hon JK, Hirsh V, Dakhil SR, Page RD, Orsini J, Zhang H, Renschler MF. Safety and efficacy of weekly nab(R)-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Feb;24(2):314-321. doi: 10.1093/annonc/mds461. Epub 2012 Nov 2.

    PubMed 23123509

  • Satouchi M, Okamoto I, Sakai H, Yamamoto N, Ichinose Y, Ohmatsu H, Nogami N, Takeda K, Mitsudomi T, Kasahara K, Negoro S. Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer. 2013 Jul;81(1):97-101. doi: 10.1016/j.lungcan.2013.02.020. Epub 2013 Mar 30.

    PubMed 23545279

  • Socinski MA, Okamoto I, Hon JK, Hirsh V, Dakhil SR, Page RD, Orsini J, Yamamoto N, Zhang H, Renschler MF. Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Sep;24(9):2390-6. doi: 10.1093/annonc/mdt235. Epub 2013 Jul 10.

    PubMed 23842283

  • Hirsh V, Okamoto I, Hon JK, Page RD, Orsini J, Sakai H, Zhang H, Renschler MF, Socinski MA. Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Jan;9(1):83-90. doi: 10.1097/JTO.0000000000000011.

    PubMed 24346096

  • Loureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062.

    PubMed 37922432

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albumin-bound paclitaxel, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Carcinoma, run by Celgene at 37 sites in 2 countries.

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 9 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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Aug 2013). 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?

Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment (time frame: Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 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 NCT00540514, which also lists 9 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 29 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in