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Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC


OBJECTIVES:

Primary

- Determine the therapeutic activity of neoadjuvant induction therapy comprising
gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung
cancer undergoing surgery.

Secondary

- Determine the safety profile of this regimen in these patients.

- Determine the stage downsizing and complete resectability rate in patients with no
progressive disease who undergo surgery after treatment with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1, 8,
22, 29, 43, and 50; cisplatin IV over 3-6 hours on days 2, 23, and 44; and oral gefitinib
once daily on days 51-79. Treatment continues in the absence of disease progression or
unacceptable toxicity. Within 2-7 days after completion of induction therapy, patients with
no progressive disease undergo tumor resection.

After completion of study treatment, patients are followed at least every 3 months for 2
years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary non-small cell lung cancer (NSCLC)

- Clinical stage IIIA by chest CT scan

- Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or
video-assisted thoracic surgery

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan

- Planning to undergo lobectomy or pneumonectomy after induction therapy

- No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT
scan or ultrasound of the liver and adrenal glands

- No pleural or pericardial effusion

- No superior vena cava syndrome

- No diffuse interstitial pulmonary fibrosis

- No signs or symptoms of CNS involvement

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

Hepatic

- AST and ALT ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin normal

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.25 times ULN

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No medically uncontrolled congestive heart failure or angina pectoris

- No uncontrolled hypertension or arrhythmia

- No myocardial infarction within the past year

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Physically and mentally fit to receive gemcitabine- and cisplatin-containing
chemotherapy

- Physiologically fit to undergo surgery

- No uncontrolled, active infection requiring IV antibiotics

- No history of hypersensitivity to gefitinib or any of its excipients

- No motor or sensory neurotoxicity ≥ grade 2

- No other primary malignancy within the past 5 years except carcinoma in situ of the
cervix or adequately treated basal cell skin cancer

- No prior melanoma, breast cancer, or renal cell cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent antiestrogen therapy

- Concurrent replacement steroids and antiemetic steroids allowed

Radiotherapy

- No prior radiotherapy for NSCLC

Surgery

- See Disease Characteristics

- No prior surgery for NSCLC

Other

- More than 1 month since prior and no concurrent investigational agents

- No other prior therapy for NSCLC

- No concurrent CYP3A4 inducers, including any of the following:

- Phenytoin

- Carbamazepine

- Rifampin

- Barbiturates (e.g., phenobarbital)

- Hypericum perforatum (St. John's wort)

- No concurrent systemic retinoids

- No other concurrent antitumor therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate as measured by RECIST criteria prior to surgery

Safety Issue:

No

Principal Investigator

Nico Van Zandwijk, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

United States: Federal Government

Study ID:

EORTC-08013

NCT ID:

NCT00103051

Start Date:

December 2004

Completion Date:

Related Keywords:

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

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