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Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)


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

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Trial Information

Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

- Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated
stage IIIA non-small cell lung cancer.

- Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days
1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage IIIA non-small cell lung cancer
(NSCLC) (T1-3, N2, M0)

- Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes

- Measurable disease

- Must be at least 20 mm in one dimension by conventional techniques or at least
10 mm by spiral CT scan

- No distant metastases

- No CNS involvement

- No pleural or pericardial effusion

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- AST/ALT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.25 ULN

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No superior vena cava syndrome

- No uncontrolled congestive heart failure or angina

- No myocardial infarction within past year

- No uncontrolled hypertension or arrhythmia

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent active infection requiring IV antibiotic therapy

- No other prior malignancy in past 5 years except carcinoma in situ of the cervix or
adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and
hypernephroma

- No concurrent illness or medical condition which is a contraindication for
corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)

- No motor or sensory neurotoxicity of grade 2 or greater

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy

Radiotherapy:

- No prior radiotherapy for NSCLC

- No concurrent radiotherapy

Surgery:

- No prior surgery for NSCLC

Other:

- At least 1 month since prior investigational agents

- No other concurrent experimental medications

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-08984

NCT ID:

NCT00005868

Start Date:

March 2000

Completion Date:

Related Keywords:

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

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