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Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer

Trial Status: Active

The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone

Inclusion Criteria

  • Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
  • At least 1 unirradiated target lesion measurable by RECIST
  • Adequate hematologic, renal and hepatic function
  • ECOG 0,1
  • Able to understand and sign an Informed Consent

Exclusion Criteria

  • Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
  • Received prior systemic anti-cancer therapy for NSCLC
  • History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
  • Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
  • History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years
  • Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
  • Serious active infection
  • Psychiatric illness/social situations that would limit study compliance
  • Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic
  • Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
  • Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
  • Known HIV positive or on active anti-retroviral therapy
  • Known Hepatitis B surface antigen positive or hepatitis C positive
  • Receipt of any investigational medication within 4 weeks prior to randomization
  • Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment
  • Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
  • Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

California

Duarte
City of Hope Comprehensive Cancer Center
Status: COMPLETED

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: COMPLETED

North Carolina

Durham
Duke University Medical Center
Status: COMPLETED

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Agennix

Principal Investigator
unknown unknown

  • Primary ID LF-0208
  • Secondary IDs NCI-2009-01425
  • Clinicaltrials.gov ID NCT00706862