• Return to search results
• Start new search

Investigator(s):
Giuseppe Giaccone, M.D., Ph.D. Principal Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Corrine Keen, R.N., M.S., O.C.N. Research Nurse Phone: 301-496-3778 ckeen@mail.nih.gov	Arlene Berman, R.N., M.S., O.C.N. Research Nurse Phone: 301-435-5609 arleneb@mail.nih.gov

---

Primary Eligibility:

• Histologically or cytologically confirmed Stage IIIB or IV non-small cell lung cancer (NSCLC)
• Failed ≥ 2 prior systemic anticancer therapies for advanced or metastatic NSCLC
• Failure is defined as disease progression or unacceptable toxicity
• Must have received a platinum-containing regimen
• Must have failed most recent systemic anticancer regimen
• ≥ 1 target lesion that is unirradiated and measurable by RECIST criteria
• Patients with brain metastases are eligible, provided:
• > 4 weeks since patient received brain irradiation and adequate stereotactic radiosurgery
• Stable, asymptomatic, and off steroids for ≥ 3 weeks
• Recovered from all prior therapy
• Karnofsky performance status (PS) 60–100% OR ECOG PS 0–2
• ANC ≥ 2,000/mm³; lymphocytes ≥ 800/mm³; platelet count ≥ 100,000/mm³; hemoglobin ≥ 9 g/dL; total bilirubin ≤ 1.5 mg/dL; creatinine ≤ 2 mg/dL; AST and ALT ≤ 2.5 x upper limit of normal (ULN); lactate dehydrogenase ≤ 1.5 x ULN
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 30 days after completion of study therapy
• No medical condition that would preclude study participation
• No history of other malignancies except for:
• Adequately treated basal or squamous cell carcinoma of the skin
• Curatively treated in situ carcinoma of the cervix, prostate cancer, or superficial bladder cancer
• Other curatively treated solid tumor with no evidence of disease for ≥ 5 years
• HIV, hepatitis C and hepatitis B negative
• No history of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin
• No GI tract disease or other medical condition resulting in the inability to take oral medications

---

Study Outline:

This is a multicenter study. Patients are stratified according to the number of prior regimens received for advanced or metastatic disease (2 vs ≥ 3), performance status (ECOG 0–1 or Karnofsky 80–100% vs ECOG 2 or Karnofsky 60–70%), and geographical region (North America vs European Union vs rest of the world). Patients are randomized to one of two treatment arms.

Arm I:


• Patients receive oral talactoferrin twice daily for 12 weeks
• Treatment repeats every 14 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity


Arm II


• Patients receive oral placebo twice daily for 12 weeks
• Treatment repeats every 14 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity

• After completion of study therapy, patients are followed every month for 1 year

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 8/21/09