Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

Description

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Study Start Date

September 2014

Estimated Completion Date

July 2017

Interventions

  • Drug: Topotecan
  • Drug: Aldoxorubicin

Specialties

  • Pulmonology:
  • Oncology:
  • Pharmacy: Chemotherapy/Oncology

MeSH Terms

  • Aldoxorubicin
  • Lung Neoplasms

Study ID

CytRx -- ALDOXORUBICIN-P2-SCLC-01

Status

Unknown

Trial ID

NCT02200757

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

132

Sponsor

CytRx

Inclusion Criteria

    1. Age ?18 years male or female. 2. Histological confirmation of SCLC. 3. Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation. 4. Capable of providing informed consent and complying with trial procedures. 5. ECOG PS 0-2. 6. Life expectancy >8 weeks. 7. Measurable tumor lesions according to RECIST 1.1 criteria.[22] 8. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.) 9. Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment. 10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. 11. Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Exclusion Criteria

    1. Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin. 2. Prior treatment with topotecan. 3. Palliative surgery and/or radiation treatment < 21 days prior to date of randomization. 4. Exposure to any investigational agent within 30 days of date of randomization. 5. Exposure to any systemic chemotherapy within 21 days of date of randomization. 6. Active (symptomatic) central nervous system (CNS) metastasis. 7. History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ?3 years. 8. Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL. 9. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D). 10. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F). 11. Baseline QTc >470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed. 12. History or signs of active coronary artery disease with angina pectoris within the last 6 months. 13. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal. 14. Known history of HIV infection. 15. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. 16. Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir. 17. Major surgery within 30 days prior to date of randomization. 18. Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. 19. Any condition that is unstable and could jeopardize the subject's participation in the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (17)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles None None None
Penn State Hershey Cancer Institute - Hershey, Pennsylvania 188.9 miles Heather Austin 772-408-5158 haustin@hemoncfl.com
Bay Hematology Oncology - Easton, Maryland 225.8 miles None None None
Oncology Hermatology Care Inc - Cincinnati, Ohio 602.2 miles Patient Hotline 877-691-7274 askSarah@scresearch.net
Tennessee Cancer Specialists - Knoxville, Tennessee 687.2 miles Susie Owen 865-934-2672 sowenby@biomed-research.com
James Graham Brown Cancer Center - Louisville, Kentucky 696.1 miles Jennifer Schoenbachler 502-562-3429 jmgoyn01@louisville.edu
Tennessee Oncology - Cattanooga, Tennessee 781.8 miles Hotline 877-691-7274 askSarah@scresearch.net
Northwest Georgia Oncology Centers PC - Marietta, Georgia 797.5 miles Melissa Lee 770-281-5131 mlee@ngoc.com
Sarah Cannon Research Institute - Nashville, Tennessee 810.5 miles None None None
Washington University School of Medicine Department of Internal Medicine - St. Louis, Missouri 919.8 miles Meredeth Melissa 314-362-4140 mmeredit@dom.wustl.edu
Hematoloy Oncology Associates - Port St. Lucie, Florida 1,039.1 miles None None None
Lynn Cancer Institute - Boca Raton, Florida 1,102.6 miles None None None
West Jefferson Medical Center Cancer Center - Marrero, Louisiana 1,230.9 miles None None None
University of Colorado Cancer Center - Aurora, Colorado 1,658.2 miles None None None
Northwest CCOP Kaiser Permanente - Portland, Oregon 2,466.8 miles Rhonda Stephenson 503-331-6537 rhonda.stephenson@kpchr.org
City of Hope Medical Group - Pasadena, California 2,482.9 miles New Patient Services 626-256-4673 None
CedarsSinai Medical Center - Los Angeles, California 2,495.4 miles Cynthia Martin 910-423-2276 cynthia.martin@cshs.org

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