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A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer


- Compare the major objective response (complete and partial response) rates in patients
with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus
low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.

- Compare the duration of response, time to progression, and survival of patients treated
with these regimens.

- Characterize and compare the toxicities of these regimens.

- Determine the recommended phase III dose of erlotinib hydrochloride.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to gender. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2.
Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes on day 3.

- Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and
carboplatin as in arm I.

In both arms, treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Inclusion Criteria


- Pathologically confirmed non-small cell lung cancer

- Stage IIIB or IV or recurrent disease

- Measurable or evaluable indicator lesions

- Must have smoked ≥ 100 cigarettes in his/her lifetime


- Karnofsky performance status 70-100%

- WBC ≥ 4,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min

- Bilirubin ≤ 1.0 mg/dL

- AST ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 1 week after
completion of study treatment

- No gastrointestinal tract disease or inability to take oral medication

- No prior malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other active medical problems, including severe infection, unstable angina, or
myocardial infarction within the past 6 months

- No poorly controlled hypertension or severe malnutrition

- No New York Heart Association class III or IV congestive heart failure or serious
cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e.,
atrial fibrillation or paroxysmal supraventricular tachycardia)


- At least 3 weeks since prior radiotherapy to major bone marrow-containing sites

- No prior chemotherapy for advanced non-small cell lung cancer

- No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis
(e.g., gefitinib, cetuximab, or trastuzumab [Herceptin®])

- No prior surgical procedure resulting in abnormal absorption of oral medications

- No concurrent surgical resection, palliative radiotherapy, or hormonal therapy

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major objective response rate (complete and partial response)

Safety Issue:


Principal Investigator

Charles M. Rudin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

JHOC-J0432, CDR0000455116



Start Date:

November 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410