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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00540514
Other study ID # CA031
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1, 2007
Est. completion date February 1, 2013

Study information

Verified date October 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 1052
Est. completion date February 1, 2013
Est. primary completion date October 1, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 [ßhCG]) 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:

- 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.

Study Design


Intervention

Drug:
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).

Locations

Country Name City State
Canada William Osler Health Centre, Brampton Clinic Brampton Ontario
Canada Hopital du Sacre-Coeur de Montreal Montreal Quebec
Canada McGill University- Dept. of Oncology Montreal Quebec
Canada Royal Columbian Hospital New Westminster British Columbia
Canada Princess Margaret Hospital Toronto Ontario
Canada Toronto East General Hospital Toronto Ontario
United States Cancer Outreach Associates, PC Abingdon Virginia
United States Phoebe Cancer Center Albany Georgia
United States Pacific Cancer Medical Center, Inc. Anaheim California
United States Comprehensive Blood and Cancer Center Bakersfield California
United States Mercy Medical Center Baltimore Maryland
United States Essex Oncology of North Jersey Belleville New Jersey
United States Fletcher Allen Health Care Burlington Vermont
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Dallas Oncology Consultants, PA Duncanville Texas
United States Southwest Cancer Care Escondido California
United States The Center for Cancers and Blood Disorders Fort Worth Texas
United States Robert A. Moss, MD, FACP, Inc. Fountain Valley California
United States Genesis Cancer Center- Hot Springs Hot Springs Arkansas
United States Clearview Cancer Institute Oncology Specialties, P.C. Huntsville Alabama
United States St. Mary Medical Center- Oncology, Hematology PC Langhorne Pennsylvania
United States Little Rock Hematology Oncology Associates Little Rock Arkansas
United States Pacific Shores Medical Group Long Beach California
United States Kentuckiana Cancer Institute, PLLC Louisville Kentucky
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States Comprehensice Cancer Ctr. Palms Springs California
United States Mercy Hospital Portland Maine
United States St. Louis University Saint Louis Missouri
United States Gulf Coast Oncology Associates Saint Petersburg Florida
United States Maine Center for Cancer Medicine Scarborough Maine
United States Lake County Oncology and Hematology, PA Tavares Florida
United States Blood and Cancer Center of East Texas Tyler Texas
United States Tyler Hematology Oncology Tyler Texas
United States Cancer Center of Kansas Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (8)

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 f — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell l — View Citation

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 no — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology 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).
Histology was determined at the time of primary diagnosis.
Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
Other Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 38 months
Other Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 38 months
Other Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 38 months
Other Time to Improvement of = Grade 3 Treatment Related Peripheral Neuropathy Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.
Improvement in peripheral neuropathy was evaluated as:
Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade;
Time to improvement of grade 3 or higher peripheral neuropathy to grade 1.
Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events.
38 months
Primary 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 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.
Assessed every 6 weeks until progression or death, up to 38 months
Secondary 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. Up to 38 months
Secondary 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. Assessed every 6 weeks, up to 22 months
Secondary 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. Assessed every 6 weeks, up to 38 months
Secondary 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. Up to 38 months
Secondary Pharmacokinetic (PK) Parameters Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.
Secondary 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).
Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.
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