Protocol Number: 09-C-0018
(Bullet) Patients with stage IIIB/IV NSCLC have a very poor prognosis despite chemotherapy, and radiation treatments. After second line therapy their median survival is between 6-8 months. (Bullet) Talactoferrin alfa (TLF) is a recombinant human lactoferrin, that displays anti-infective and anti-inflammatory properties, anti-tumor activity and anti-asthma properties. (Bullet) Previous studies in NSCLC demonstrated evidence of clinical activity. In A randomized, double blind, placebo controlled, Phase II study of oral recombinant human lactoferrin (rhLF) monotherapy in patients with stage IIIB/IV NSCLC who have failed 1st or 2nd line chemotherapy showed a 2.3 months increase in median Overall Survival (p less than 0.05, one-tailed). Talactoferrin appeared to be well tolerated in this study. Objectives: (Bullet) Primary: Compare overall survival between Talactoferrin arm and placebo arm (Bullet) Secondary Objectives: Compare six month and one year survival rate, progression-free survival, objective tumor response rate, disease stabilization rate and safety and tolerability between Talactoferrin arm and placebo arm (Bullet) Tertiary Objective: Compare Quality of Life in English-speaking patients between Talactoferrin arm and placebo arm Inclusion Criteria: (Bullet) Age greater than or equal to 18 years, histologically or cytologically confirmed stage IIIB/IV NSCLC confirmed at the NCI Lab of Pathology prior to starting treatment (Bullet) Received at least 2 prior systemic anti-cancer therapies for stage IIIB/IV NSCLC, one of which was a platinum-containing regimen. (Bullet) At least one target lesion that is unirradiated and measurable by RECIST (Bullet) Adequate organ function and Karnofsky PS of greater than 50 (ECOG 0, 1, or 2) Exclusion Criteria: (Bullet) History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or any GI tract disease resulting in the inability to take oral medications Design: (Bullet) This is a double blind, placebo-controlled, multicenter, Phase III study. Approximately 720 patients will be randomized at a ratio of 2:1 to the talactoferrin or placebo arm, respectively. (Bullet) The two study arms are as follows: (Bullet) Arm 1: Talactoferrin 1.5 g bid orally (Bullet) Arm 2: Placebo bid orally Each talactoferrin or placebo cycle will include 12 weeks (84 days) on study drug and 2 weeks (14 days) off study drug. Patients will receive talactoferrin or placebo for up to a maximum of five 14-week cycles (70 weeks), until the occurrence of progressive disease, start of a next-line therapy for NSCLC, unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first. (Bullet) Evaluation will be performed at baseline, at week 7 and week 14 and then every cycle (14 weeks) with CT Chest/Abdomen. (Bullet) This study is designed to have approximately 85% power to detect a 30% improvement in median Overall Survival (OS) in patients in the intent to treat population, from 4.6 months in the placebo arm to 6.0 months in the talactoferrin arm with a two-sided p-value of 0.05.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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