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

Non Small Cell Lung Cancer Clinical Trial

— FORTIS-C  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00706862
• Other study ID #: LF-0208
• Status: Recruiting
• Phase: Phase 3
• First received: June 26, 2008
• Last updated: March 13, 2012
• Start date: February 2009
• Est. completion date: March 2016

Study information

• Verified date: March 2012
• Source: Agennix
• Contact: Yenyun Wang, MD
• Phone: 713-552-1091
• Email: ywang[@]agennix.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Talactoferrin
Oral, 1.5 grams twice per day
• Placebo
Oral, twice per day

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Chattanooga Oncology and Hematology Associates	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		After the occurence of the required number of events	No
Primary	Progression free survival		At the time of final analysis	No
Secondary	Objective response and disease stabilization rate		At the time of final analysis	No
Secondary	Safety and tolerability		At the time of final analysis	No