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Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

Erlotinib (Tarcevaâ, OSI-774) is a drug that helps to block the activity of an enzyme that
is believed to play an important role in cell growth. It is hoped that blocking these
enzymes will slow tumor growth. Both cisplatin and docetaxel (Taxotereâ) are commonly used
chemotherapy drugs. These drugs are designed to target and destroy cancer cells.

If you are found to be eligible, you will begin receiving chemotherapy with cisplatin and
docetaxel. Cisplatin and docetaxel will be given by vein once every 3 weeks. Both will be
given on the same day every 3 weeks. Docetaxel is given first over 1 hour. Cisplatin is
given second over 30 minutes to 1 hour. You will receive three 3-week cycles of
chemotherapy while on this study. Treatment with erlotinib will begin after you have had
surgery to remove the lung cancer. You will take erlotinib by mouth every day for the
remainder of your treatment on this study.

While taking chemotherapy, you will have blood tests every 3 weeks to look at your blood
counts. This is to ensure that your body has recovered from the chemotherapy enough to
continue treatment. About 2 teaspoons of blood will be needed for each test. These samples
will be used only for routine lab tests. You will be seen by a physician every 3 weeks. At
these visits, you will have a physical exam and a chest x-ray. You may have a neurological
exam if your doctor thinks it is necessary. This exam will look at whether you have any
numbness, test your hearing and vision, and will include other standard evaluations. Your
vital signs and weight will be monitored and you will be asked about certain side effects.
If necessary, depending on your side effects, you may need to have more frequent visits to
see your physician.

After 3 cycles of chemotherapy (9 weeks), you will have a CT scan of the chest and abdominal
area, and possibly a CT scan of the area where the disease may be coming back. These are
done to check the status of the disease.

Within 90 days after surgery, you will begin taking erlotinib. On Day 1 of erlotinib
treatment, you will have a physical exam, a performance status evaluation (questions about
your ability to perform everyday activities), a chest x-ray, and blood drawn (about 2
teaspoons) for routine tests. These tests will be repeated at Month 2, Month 3, then every 3
months after that.

On Day 1 of erlotinib treatment and every 3 months after that, you will also have a CT scan
of the chest and abdominal area, and possibly a CT scan of the area where the disease may be
coming back.

You may receive treatment in the study for up to 1 year (3 cycles of cisplatin/docetaxel and
then daily erlotinib for up to 1 year) and will receive long-term follow-up (for 5 years
total) with your physician to monitor your condition and disease status. Your doctor may
decide to take you off this study if you experience significant side effects or your medical
condition worsens. Follow-up visits will include a chest x-ray and CT scan every 3 months
during Year 2 and then every 6 months until Year 5.

This is an investigational study. Erlotinib is approved by the FDA for treatment of
non-small cell lung cancer. Its use in this study is experimental. Docetaxel and cisplatin
are FDA approved and commercially available. A total of 50 patients will take part in this
study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed diagnosis of stage I, II
or III non-small cell lung cancer. Tissue blocks or slides will be requested.

2. Patients must have surgically resectable disease and may not be treated with prior
chemotherapy or radiation.

3. Patients must be able to tolerate systemic chemotherapy prior to surgical resection.

4. Age >=18 years

5. No acute intercurrent illness or infection.

6. ECOG performance status 0-1

7. Normal organ and marrow function defined as: a) leukocytes >=3,000/uL, ANC>=1,500/uL,
platelets>=100,000/uL, hemoglobin>=8g/dL, creatinine w/in normal institutional limits
OR b) creatinine clearance>=60 mL/min/1.73 m**2 for patients with creatinine levels
above institutional normal, bilirubin w/in normal institutional limits, alk
phos<=2.5xULN AND AST or ALT<=1.5xULN. If alk phos>2.5xULN but <=5xULN, pt is
eligible if AST or ALT<=ULN. If AST or ALT>1.5xULN but <=5xULN, pt is eligible if alk
phos is <=ULN.

8. Prior to study enrollment, all women of child-bearing potential must have a negative
pregnancy test. Women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry, for the duration of study participation, and for 2 months after the
completion of therapy. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her treating physician

9. Patients with a history of non-melanoma skin cancer, or other malignancies treated 5
years or more prior to the current tumor, from which the patient has remained
continually disease-free, are eligible.

10. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Patients who have had prior chemotherapy or radiotherapy for lung cancer.

2. Patients may not be receiving any other investigational agents within 30 days of
trial entry, including anti-EGFR drugs.

3. Patient has signs or symptoms of acute infection requiring systemic therapy.

4. Patient exhibits confusion, disorientation, or has a history of major psychiatric
illness that may impair patient's understanding of the informed consent.

5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (New York Heart Association
Functional Classification class II or worse), unstable angina pectoris, serious or
clinically significant cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.

6. Patients refusing to sign the informed consent.

7. Patients with pre-existing peripheral neuropathy NCI CTC grade 2 or worse.

8. Patients must not be pregnant or breast-feeding and all (male and female) must use a
contraceptive method deemed acceptable by the investigator while receiving active
treatment in the study and for up to two months following completion of therapy.

9. Patients with a history of severe hypersensitivity reaction to Taxotere® and or
polysorbate 80 must be excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

William N. William Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Cisplatin
  • Platinol
  • Platinol-AQ
  • CDDP
  • Docetaxel
  • Taxotere
  • Erlotinib
  • Tarceva
  • OSI-774
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030