Clinical trial NCT00706862: Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer
Official title: FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer
Talactoferrin
Dendritic cell recruiter and activator
DCRA
Immunomodulatory agent
Lactoferrin
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2008-06-30
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: After the occurence of the required number of events
measure: Progression free survival
timeFrame: At the time of final analysis
Secondary outcomes:
measure: Objective response and disease stabilization rate
timeFrame: At the time of final analysis
measure: Safety and tolerability
timeFrame: At the time of final analysis
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
References: