Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005868

Enrollment

Registered

2003-05-21

Start date

2000-03-31

Completion date

Unknown

Last updated

2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.

Detailed description

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.

Interventions

DRUGcisplatin

DRUGdocetaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Countries

Germany, Italy, Netherlands, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026