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Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Squamous Cell Carcinoma, Non-Small-Cell Lung

Intervention: Abraxane (Induction) (Drug); Carboplatin (Induction) (Drug); Abraxane (Maintenance) (Drug); Best Supportive Care (Maintenance) (Other); Abraxane (Induction) (Drug); Carboplatin (Induction) (Drug); Best Supportive Care (Maintenance) (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Teng Jin Ong, MD, Study Director, Affiliation: Celgene Corporation

Overall contact:
Duong Ngyuen, Pharm. D., Phone: (415) 839-7097, Email: dnguyen@celgene.com

Summary

Maintenance treatment of advanced stage squamous cell NSCLC

Clinical Details

Official title: A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-paclitaxel (Abraxane) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progress free survival from randomization to the maintainence part of the study

Secondary outcome:

Adverse Events

Efficacy - overall survival from randomization into the maintainence part of the study.

Efficacy - overall response rate during the induction and maintainence part of the study.

Detailed description: Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or SD with nab-paclitaxel plus carboplatin as induction in subjects with stage IIB/IV squamous cell NSCLC.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1. Age ≥ 18 years of age at the time of signing the Informed Consent Form. 2.

Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures. 3. Able to adhere to the study visit schedule and other protocol requirements Disease Specific 4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry. 5. No other current active malignancy requiring anticancer therapy. 6. Radiographically documented measurable disease at study entry (as defined by the RECIST v1. 1 criteria). 7. No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence. 8. Absolute neutrophil count ≥ 1500 cells/mm3. 9. Platelets ≥ 100,000 cells/mm3. 10. Hemoglobin ≥ 9 g/dL. 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 × upper limit of normal range except in cases of Gilbert's disease and liver metastases. 13. Creatinine ≤ 1. 5 mg/dL. 14. Expected survival of > 12 weeks for the Induction part of the study. 15. Eastern Cooperative Oncology Group performance status 0 or 1. 16. For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction Pregnancy 17. Females of childbearing potential [defined as a sexually mature woman 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 (i. e., has had menses at any time during the preceding 24 consecutive months)] must: 1. agree to take a pregnancy test prior to starting study medication and throughout the study participation. 2. commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations. Male subjects must: 3. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy. 18. Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation. Exclusion Criteria:

- The presence of any of the following will exclude a subject from enrollment into the

Induction and Maintenance parts of the study (except if specified at study entry only): 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 first dose of study drug). 2. Only evidence of disease is non measurable at study entry. 3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4. 0). 4. Venous thromboembolism within 6 months prior to signing Informed Consent Form. 5. Current congestive heart failure (New York Heart Association class II-IV). 6. 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 (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. 7. Treatment with any investigational product within 28 days prior to signing Informed Consent Form. 8. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 9. Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices. 10. Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol. 11. Subject 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 (TNM stage of T1a or T1b) — all treatments that should have been completed 6 months prior to signing ICF. 12. Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting IP, 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. 13. Pregnant and nursing females.

Locations and Contacts

Duong Ngyuen, Pharm. D., Phone: (415) 839-7097, Email: dnguyen@celgene.com

Clearview Cancer Institute, Huntsville, Alabama 35805, United States; Recruiting

Banner MD Anderson Cancer Center, Gilbert, Arizona 85234, United States; Not yet recruiting

Palo Verde Hematology Oncology Ltd, Glendale, Arizona 85304, United States; Recruiting

Arizona Clinical Research Center, Tucson, Arizona 85715, United States; Recruiting

Genesis Cancer Center, Hot Springs, Arkansas 71913, United States; Recruiting

City of Hope National Medical Center, Duarte, California 91010, United States; Active, not recruiting

California Cancer Associates for Research and Excellence, Encinitas, California 92024, United States; Not yet recruiting

California Cancer Associates for Research and Excellence, Encinitas, California 92024, United States; Recruiting

UC San Diego Moores Cancer Center, La Jolla, California 92093, United States; Not yet recruiting

Clinical Trials and Research Associates Inc, Montebello, California 90640, United States; Recruiting

Rocky Mountain Cancer Centers, LLP, Denver, Colorado 80218, United States; Recruiting

Yale Cancer Center, New Haven, Connecticut 06520, United States; Recruiting

Lynn Cancer Institute, Boca Raton, Florida 33486, United States; Recruiting

Florida Cancer Specialists, Fort Myers, Florida 33916, United States; Recruiting

Center For Cancer Care and Research, Lakeland, Florida 33805, United States; Recruiting

University of Miami, Miami, Florida 33136, United States; Active, not recruiting

Ocala Oncology Center, Ocala, Florida 34471, United States; Recruiting

Orlando Health, Inc, Orlando, Florida 32806, United States; Active, not recruiting

Memorial Cancer Institute, Pembroke Pines, Florida 33028, United States; Recruiting

Moffitt Cancer Center, Tampa, Florida 33612-9497, United States; Recruiting

Florida Cancer Specialists (TAV), Tavares, Florida 32778, United States; Recruiting

University Cancer and Blood Center, LLC, Athens, Georgia 30607, United States; Recruiting

Northwest Georgia Oncology Centers PC, Marietta, Georgia 30060, United States; Not yet recruiting

University of Chicago, Chicago, Illinois 60637, United States; Recruiting

Joliet Oncology-Hematology, Joliet, Illinois 60435, United States; Recruiting

Illinois Cancer Specialists, Niles, Illinois 60714, United States; Recruiting

Indiana University Cancer Center, Indianapolis, Indiana 46202, United States; Recruiting

Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana 46260, United States; Recruiting

University of Kansas Cancer Center and Medical Pavillion, Westwood, Kansas 66205, United States; Recruiting

Kentucky Cancer Clinic, Hazard, Kentucky 41701, United States; Not yet recruiting

University of Kentucky, Lexington, Kentucky 40536, United States; Not yet recruiting

Norton Cancer Institute - Pavilion, Louisville, Kentucky 40202, United States; Recruiting

University of Louisville, Louisville, Kentucky 40202, United States; Not yet recruiting

LSU Health Sciences Center, New Orléans, Louisiana 70112, United States; Recruiting

Maine Research Associates, Auburn, Maine 04210, United States; Recruiting

Eastern Maine Medical Center, Brewer, Maine 04412, United States; Recruiting

Center For Cancer and Blood Disorders, Bethesda, Maryland 20817, United States; Recruiting

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting

Detroit Clinical Research Center, Farmington Hills, Michigan 48334, United States; Recruiting

Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan 49503, United States; Not yet recruiting

Mercy Clinic - Cancer & Hematology, Springfield, Missouri 65804, United States; Recruiting

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting

Englewood Hospital and Medical Center, Englewood, New Jersey 07631, United States; Recruiting

Regional Cancer Care Associates, Morristown, New Jersey 07962, United States; Recruiting

New York Oncology Hematology, P.C., Albany, New York 12208, United States; Recruiting

Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting

Clinical Research Alliance Inc, Lake Success, New York 11042, United States; Recruiting

NYU Langone Medical Center, Lake Success, New York 11042, United States; Recruiting

Beth Israel New York, New York, New York 10003, United States; Recruiting

Mount Sinai Medical Center, New York, New York 10029, United States; Recruiting

NYU Cancer Institute, New York, New York 10016, United States; Active, not recruiting

Rochester General Hospital, Rochester, New York 14621, United States; Recruiting

Upstate Medical University, Syracuse, New York 13210, United States; Recruiting

Carolinas Medical Center, Charlotte, North Carolina 28204, United States; Recruiting

Southeastern Medical Oncology Center, Goldsboro, North Carolina 27534, United States; Recruiting

Cone Health Cancer Center, Greensboro, North Carolina 27403, United States; Active, not recruiting

Hematology and Oncology Associates, Inc., Canton, Ohio 44708, United States; Recruiting

Oncology Hematology Care Inc, Cincinnati, Ohio 45242, United States; Recruiting

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting

Mark H. Zangmeister Center, Columbus, Ohio 43219, United States; Recruiting

Toledo Community Oncology Program, Toledo, Ohio 43617, United States; Not yet recruiting

Mercy Clinic Oklahoma Communities, Inc, Oklahoma City, Oklahoma 73102, United States; Recruiting

University of Oklahoma, Oklahoma City, Oklahoma 73104, United States; Recruiting

Providence Cancer Center, Portland, Oregon 97213, United States; Not yet recruiting

Erie Regional Cancer Center, Erie, Pennsylvania 16505, United States; Active, not recruiting

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States; Not yet recruiting

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Not yet recruiting

University of Pittsburgh, Pittsburgh, Pennsylvania 15232, United States; Recruiting

Greenville Healthy System, Greenville, South Carolina 29605, United States; Recruiting

Associates In Oncology and Hematology, Chattanooga, Tennessee 37421, United States; Recruiting

Tennessee Oncology-Chattanooga, Chattanooga, Tennessee 37404, United States; Recruiting

Thompson Cancer Survival Center, Knoxville, Tennessee 37916, United States; Recruiting

Tennessee Oncology PLLC, Nashville, Tennessee 37203, United States; Recruiting

Vanderbilt Ingram Cancer Center, Nashville, Tennessee 37232, United States; Recruiting

Texas Oncology- Beaumont Mamie MacFadding Ward, Beaumont, Texas 77706, United States; Recruiting

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States; Recruiting

Center For Cancer and Blood Disorders, Fort Worth, Texas 76104, United States; Recruiting

Brooke Army Medical Center, Ft. Sam Houston, Texas 78235, United States; Not yet recruiting

Baylor College of Medicine, Houston, Texas 77030, United States; Not yet recruiting

Houston Methodist Cancer Center, Houston, Texas 77030, United States; Recruiting

Millennium Oncology, Houston, Texas 77090, United States; Recruiting

UT Health Oncology, Houston, Texas 77030, United States; Not yet recruiting

Texas Oncology, PA, Tyler, Texas 75702, United States; Recruiting

Columbia Basin Hematology and Oncology, Kennewick, Washington 99336, United States; Recruiting

Swedish Cancer Institute, Seattle, Washington 98104, United States; Recruiting

St Mary's Medical Center, Huntington, West Virginia 25702, United States; Recruiting

Berkeley Medical Center, Martinsburg, West Virginia 25401, United States; Recruiting

West Virginia University Hospital, Morgantown, West Virginia 26506, United States; Not yet recruiting

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting

Additional Information

Starting date: December 2013
Last updated: June 19, 2015

Page last updated: August 23, 2015

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