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

NCT00540514 | Completed Phase 3 Results DMC

• 1 other identifier: CA031
• Study Type: interventional
• Target: 1,052
• Locations: 2 countries
• Sites: 37

Brief 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).

Conditions

Non-Small Cell Lung Carcinoma

Keywords

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (7)

• Progression-free Survival by Blinded Radiology Assessment

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

• Overall Participant Survival

  Up to 38 months

• Percentage of Participants With Controlled Disease

  Assessed every 6 weeks, up to 22 months

• Duration of Response in Responding Patients

  Assessed every 6 weeks, up to 38 months

• Number of Participants With Adverse Events (AEs)

  Up to 38 months

Other Outcomes (5)

• Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology

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

• Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin

  38 months

• Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count

  38 months

Study Arms (2)

Albumin-bound paclitaxel + Carboplatin

EXPERIMENTAL

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.

Drug: Albumin-bound paclitaxel; Drug: Carboplatin

Paclitaxel + Carboplatin

ACTIVE COMPARATOR

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.

Drug: Paclitaxel; Drug: Carboplatin

Interventions

Albumin-bound paclitaxel DRUG

Administered by intravenous infusion.

Also known as: ABI-007, ABRAXANE®, nab®-paclitaxel

Albumin-bound paclitaxel + Carboplatin

Paclitaxel DRUG

Administered by intravenous infusion.

Also known as: Taxol®

Paclitaxel + Carboplatin

Carboplatin DRUG

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).

Albumin-bound paclitaxel + Carboplatin; Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (37)

Clearview Cancer Institute Oncology Specialties, P.C.

Huntsville, Alabama, 35805, United States

Location

Genesis Cancer Center- Hot Springs

Hot Springs, Arkansas, 71913, United States

Location

Little Rock Hematology Oncology Associates

Little Rock, Arkansas, 72205, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Southwest Cancer Care

Escondido, California, 92064, United States

Location

Robert A. Moss, MD, FACP, Inc.

Fountain Valley, California, 92708, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Comprehensice Cancer Ctr.

Palms Springs, California, 92262, United States

Location

Gulf Coast Oncology Associates

St. Petersburg, Florida, 33705, United States

Location

Lake County Oncology and Hematology, PA

Tavares, Florida, 32778, United States

Location

Phoebe Cancer Center

Albany, Georgia, 31701, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Kentuckiana Cancer Institute, PLLC

Louisville, Kentucky, 40202, United States

Location

Mercy Hospital

Portland, Maine, 04101, United States

Location

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Essex Oncology of North Jersey

Belleville, New Jersey, 07109, United States

Location

Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

St. Mary Medical Center- Oncology, Hematology PC

Langhorne, Pennsylvania, 19047, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Dallas Oncology Consultants, PA

Duncanville, Texas, 75137, United States

Location

The Center for Cancers and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

Blood and Cancer Center of East Texas

Tyler, Texas, 75701, United States

Location

Tyler Hematology Oncology

Tyler, Texas, 75701, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

Cancer Outreach Associates, PC

Abingdon, Virginia, 24211, United States

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W4, Canada

Location

William Osler Health Centre, Brampton Clinic

Brampton, Ontario, L6R 3J7, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C3E7, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University- Dept. of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (9)

• 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.

  PMID: 24467217 BACKGROUND

• 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.

  PMID: 25572008 BACKGROUND

• 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.

  PMID: 26035702 BACKGROUND

• 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.

  PMID: 22547591 RESULT

• 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.

  PMID: 23123509 RESULT

• 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.

  PMID: 23545279 RESULT

• 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.

  PMID: 23842283 RESULT

• 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.

  PMID: 24346096 RESULT

• 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.

  PMID: 37922432 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Albumin-Bound Paclitaxel; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Mark A Socinski, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2013
• Last Updated: October 29, 2019
• Results First Posted: August 19, 2013

Record last verified: 2019-10

Locations

US (31); CA (6)