Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00540514
Last Updated: 2019-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1052 participants
INTERVENTIONAL
2007-11-01
2013-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albumin-bound paclitaxel + Carboplatin
Participants 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.
Albumin-bound paclitaxel
Administered by intravenous infusion.
Carboplatin
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).
Paclitaxel + Carboplatin
Participants 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.
Paclitaxel
Administered by intravenous infusion.
Carboplatin
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).
Interventions
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Albumin-bound paclitaxel
Administered by intravenous infusion.
Paclitaxel
Administered by intravenous infusion.
Carboplatin
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Mark A Socinski, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Clearview Cancer Institute Oncology Specialties, P.C.
Huntsville, Alabama, United States
Genesis Cancer Center- Hot Springs
Hot Springs, Arkansas, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Southwest Cancer Care
Escondido, California, United States
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Comprehensice Cancer Ctr.
Palms Springs, California, United States
Gulf Coast Oncology Associates
St. Petersburg, Florida, United States
Lake County Oncology and Hematology, PA
Tavares, Florida, United States
Phoebe Cancer Center
Albany, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States
Mercy Hospital
Portland, Maine, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
Mercy Medical Center
Baltimore, Maryland, United States
St. Louis University
St Louis, Missouri, United States
Essex Oncology of North Jersey
Belleville, New Jersey, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
St. Mary Medical Center- Oncology, Hematology PC
Langhorne, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Dallas Oncology Consultants, PA
Duncanville, Texas, United States
The Center for Cancers and Blood Disorders
Fort Worth, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Blood and Cancer Center of East Texas
Tyler, Texas, United States
Tyler Hematology Oncology
Tyler, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Cancer Outreach Associates, PC
Abingdon, Virginia, United States
Royal Columbian Hospital
New Westminster, British Columbia, Canada
William Osler Health Centre, Brampton Clinic
Brampton, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University- Dept. of Oncology
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CA031
Identifier Type: -
Identifier Source: org_study_id
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