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A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment

Study Design:

This will be a Phase II, open-label, single-center, repeat dose, study. After a two-week
screening phase, eligible subjects will receive combined docetaxel and erlotinib treatment
over six cycles. Each 22-day treatment cycle will consist of two infusion of docetaxel,
one-week apart followed by one week rest, and daily administration of erlotinib. Subjects,
who complete six cycles of combination therapy, will continue receiving erlotinib
monotherapy for as long as they are benefiting from this therapy in the opinion of the
investigator (i.e. until continued toxicity or disease progression or withdrawal from the
study). Subjects will be evaluated for safety and radiologic tumor assessment throughout the
study until death. The study will be terminated after every living patient has had a follow
up of at least 6 months after stopping TarcevaTM, or when all patients have died.

Inclusion Criteria:

1. Male or female subjects, above 18 years of age at the time of enrollment.

2. Subject aged 18-65 must have ECOG performance status of 2 and subjects above 65 must
have ECOG PS 0-2.

3. Histological or cytological documented diagnosis of inoperable, locally advanced
(with pleural effusion), recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.

4. Patients must have evidence of measurable disease with at least one measurable or
evaluable lesion.

5. Eligible for first line monotherapy treatment (or no prior chemotherapy or radiation
treatments for this indication). Palliative localized radiation is allowed.

6. Life expectancy of at least 12 weeks.

7. Adequate bone marrow function as shown by: WBC >= 3.0 x 109/L, ANC >=1.5 x 109/L,
Platelets >=100 x 109/L, Hgb >=10g/dL.

8. Subjects must have normal organ function as defined below:

- AST (SGOT) / ALT (SGPT) ≤ 2 x upper limit of normal (ULN),

- Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 ml/min

- Coagulation markers - PT and PTT (or INR) within normal limits unless subjects
are already anti-coagulated for other reasons (i.e., atrial fibrillation, etc.).

9. Signed written informed consent to participate in the study.

10. Ability to comply with the requirements of the study.

Exclusion Criteria:

1. Participation in an investigational trial within 30 days of the screening visit.

2. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to erlotinib or docetaxel.

3. Have a previous (unless disease free for more than five years) or concurrent
malignancy besides NSCLC (except for adequately treated carcinoma in situ of the
cervix or basal or squamous cell skin cancer).

4. Subjects with known brain metastases or spinal cord compression that is newly
diagnosed and/or has not yet been definitively treated with surgery and/or radiation;
previously diagnosed and treated CNS metastases or spinal cord compression with
evidence of stable disease (clinically stable imaging) for at least 2 months is

5. Subjects with preexisting neuropathy ≥ grade 2.

6. Current serious infections.

7. Current known acute or chronic infection with HBV or HCV.

8. Known human immunodeficiency virus (HIV) infection.

9. Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions. The use of
contact lenses is not recommended during the study. The decision to continue to wear
contact lenses should be discussed with the patient's treating Oncologist and the

10. Subjects with other concurrent severe and/or uncontrolled medical condition which
could compromise participation in the study (i.e. active infection, uncontrolled
diabetes, uncontrolled hypertension - grade 4, congestive cardiac failure, unstable
angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction
within six months, chronic liver or renal or metabolic disease, active upper GI tract

11. Any chronic or acute condition susceptible of interfering with the evaluation of drug

12. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder
or any chronic condition susceptible, in the opinion of the investigator, of
interfering with the conduct of the study.

13. Organ allograft or previous history of stem cell transplantation.

14. Subjects who received anti-neoplastic therapy, radiation therapy or had surgery
within 28 days prior to the start of study agent administration or who have not
recovered from the toxic effects of such therapy. Palliative localized radiation is

15. Subjects who cannot take oral medication, who require intravenous alimentation, have
had prior surgical procedures affecting absorption, or have active peptic ulcer

16. Fertile subjects who are not willing to use an acceptable method of contraception
during the treatment period and for 28 days following completion of treatment.

17. For women of child-bearing potential: A positive pregnancy test at screening or

18. Subjects who are likely to be non-compliant or uncooperative during the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

all cause mortality

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Maya Gottfried, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Meir Medical Center


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

February 2009

Completion Date:

August 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • first line treatment
  • Stage IIIB /IV
  • not previously treated
  • ECOG PS 2 or age over 65
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms