Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer
- Registration Number
- NCT00706862
- Lead Sponsor
- Agennix
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Talactoferrin Talactoferrin, Carboplatin, Paclitaxel 2 Placebo Placebo, Carboplatin, Paclitaxel
- Primary Outcome Measures
Name Time Method Overall Survival After the occurence of the required number of events Progression free survival At the time of final analysis
- Secondary Outcome Measures
Name Time Method Objective response and disease stabilization rate At the time of final analysis Safety and tolerability At the time of final analysis
Trial Locations
- Locations (6)
City of Hope
🇺🇸Duarte, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Chattanooga Oncology and Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States