Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly

NCT ID: NCT02151149

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-09
• Study Completion Date: 2017-07-14

Brief Summary

Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC

Detailed Description

This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.

Conditions

Non-Small Cell Lung Cancer; Carcinoma; Squamous Cell Carcinoma; Adenocarcinoma; Carcinoma, Large Cell; Lung Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: nab-Paclitaxel and Carboplatin (Every 21 days)

nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg\*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle

Group Type: OTHER

nab-paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Arm B: nab-Paclitaxel and Carboplatin (Every 28 days)

nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg\*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break

Group Type: OTHER

nab-paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Interventions

nab-paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Other Intervention Names

Abraxane

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 70 years at the time of signing the Informed Consent Form.

2. Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Histologically or cytologically confirmed locally advanced or metastatic non small cell lung cancer who are not candidates for curative surgery or radiation therapy.

5. No other current active malignancy requiring anticancer therapy.

6. Radiographically documented measurable disease per RECIST v 1.1

7. No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12 months prior to signing the informed consent form (ICF) and without disease recurrence. Participans with previously known epidermal growth factor receptor mutation or anaplastic lymphoma kinase gene translocation must have failed or had intolerance to one treatment with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.

8. Absolute neutrophil count ≥ 1500 cells/cubic millimetre.

9. Platelets ≥ 100,000 cells/cubic millimetre.

10. Hemoglobin ≥ 9 grams/decilitre.

11. Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.

12. Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of Gilberts Syndrome).

13. Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault equation (if renal impairment is suspected 24 hour urine collection for measurement is required).

14. Eastern Cooperative Oncology Group performance status 0 or 1.

15. Females who (1) have undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally postmenopausal for at least 24 consecutive months (ie, has not had menses at any time during the preceding 24 consecutive months).

16. Male subjects must: Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.

Exclusion Criteria

• 1. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.

2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).

5. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.

6. Venous thromboembolism within 1 month prior to signing informed consent form.

7. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.

9. Participant has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or participant is receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.

10. Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.

11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.

12. Treatment with any investigational product within 28 days prior to signing the informed consent form.

13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices. 15. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.

16. Participant has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer Tumor, Lymph Node, Metastatic (TNM stage of T1a or T1b). All treatment of which should have been completed 6 months prior to signing Informed consent form.

17. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.

18. Any medical condition that confounds the ability to interpret data from the study.

19. Females who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teng Jin Ong

Role: STUDY_DIRECTOR

Celgene

Locations

Arizona Clinical Research Center

Tucson, Arizona, United States

Genesis Cancer Center

Hot Springs, Arkansas, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Saint Jude Heritage Medical Center

Fullerton, California, United States

Global Cancer Research Institute (GCRI), Inc.

Gilroy, California, United States

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

University of California Los Angeles

Santa Monica, California, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

St Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Lynn Cancer Institute

Boca Raton, Florida, United States

Baptist Cancer Inst

Jacksonville, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Northshore University Healthsystem Research Institute

Evanston, Illinois, United States

Oncology Specialists, S.C.

Niles, Illinois, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Western Kentucky Hematology and Oncology Group

Paducah, Kentucky, United States

West Jeffersion Medical Center

Marrero, Louisiana, United States

Ochsner Medical Institutions

New Orleans, Louisiana, United States

Medstar Health Research Institute

Baltimore, Maryland, United States

Reliant Medical Group

Worcester, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Carol G Simon Cancer Center

Morristown, New Jersey, United States

Somerset Hematology-Oncology Associates

Somerville, New Jersey, United States

Regional Cancer Care Associates LLC- Sparta division

Sparta, New Jersey, United States

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

Broome Oncology, LLC

Johnson City, New York, United States

Clinical Research Alliance

Lake Success, New York, United States

SUNY Upstate Medical University Medicine Oncology

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Lineberger Cancer Center

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Forsyth Memorial Hospital, Inc.

Winston-Salem, North Carolina, United States

St Elizabeth Hospital

Youngstown, Ohio, United States

Cancer Centres of Southwest Okahoma Research

Lawton, Oklahoma, United States

Good Samaritan Hospital Corvalis

Corvallis, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Medical College

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, United States

Baylor University Medical Center at Dallas

Dallas, Texas, United States

UTMB Galveston

Galveston, Texas, United States

Texas Oncology, PA - Longview

Longview, Texas, United States

Virginia Mason Cancer Center

Seattle, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan: ABI-007-NSCL-005_SAP_AM!_Redacted.17March 2016

View Document

Document Type: Study Protocol: ABI-007-NSCL-005_PA1_Redacted.09April2014

View Document

Document Type: Statistical Analysis Plan: ABI-007-NSCL-005.OriginalSAP.Redacted24 June2016

View Document

Document Type: Study Protocol: ABI-007-NSCL-005_PA2_Redacted.05 December 2014

View Document

Document Type: Study Protocol: ABI-007-NSCL-005_PA3_Redacted.17 March 2016

View Document

Document Type: Study Protocol: ABI-007-NSCL-005_Original_Redacted.06 March2014

View Document

Other Identifiers

ABI-007-NSCL-005

Identifier Type: -

Identifier Source: org_study_id