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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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)

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

Study Design:

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

Outcome Measure:

Major objective response rate (complete and partial response)

Safety Issue:

No

Principal Investigator

Charles M. Rudin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

JHOC-J0432, CDR0000455116

NCT ID:

NCT00287989

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

Name

Location

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