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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Non-Small Cell Lung Cancer  Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
For Condition: Quality of Life,recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Istituto Nazionale per lo Studio e la Cura dei Tumori ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy. - Compare the toxicity of these regimens in these patients. - Compare the response rate, time to progression, and survival of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses. - Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses. Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) - Metastatic supraclavicular lymphadenopathy or malignant pleural effusion - Progressive disease - Must have received prior chemotherapy - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN Renal: - Creatinine no greater than 1.25 times ULN Cardiovascular: - No prior or concurrent cardiovascular disease that would preclude study Pulmonary: - See Disease Characteristics - No prior or concurrent pulmonary disease that would preclude study Other: - No prior or other concurrent illness or medical condition that would preclude study - No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior docetaxel - At least 3 weeks since other prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy allowed - No concurrent radiotherapy Surgery: - Prior radical surgery for NSCLC allowed - Concurrent palliative surgery allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CesareGridelli, Study Chair, Istituto Nazionale per lo Studio e la Cura dei Tumori
Federico II University Medical School *Recruiting*
Naples (Napoli), , 80131
Italy
Recruiting S. Cigolari 39-081-746-3772
Ospedale Luigi Sacco *Recruiting*
Milano (Milan), , 20157
Italy
Recruiting Elena Piazza 39-02-356-7031
Ospedale San Giuseppe *Recruiting*
Milano (Milan), , 20153
Italy
Recruiting Maurizia Clerici 39-02-4022-2269
Ospedale Cardarelli - Campobasso *Recruiting*
Campobasso, ,
Italy
Recruiting Sante Romito 390-874-409-447
Istituto Di Ricovero E Cura A Carattere Scientifico *Recruiting*
Bari, , 70126
Italy
Recruiting Domenico Galetta 39-080-555-5236
Istituto Di Science Biomediche San Paolo *Recruiting*
Milano, , 20142
Italy
Recruiting Luciano Frontini 39-02-8184-4583-4493
Seconda Universita di Napoli *Recruiting*
Napoli, , 80133
Italy
Recruiting Ciro Gallo 39-081-566-6726
Policlinico P. Giaccone - Universita Di Palermo *Recruiting*
Palermo, , 90127
Italy
Recruiting Nicola Gebbia 011-39-091-655-2321
Ospedale da Procida *Recruiting*
Salerno, ,
Italy
Recruiting Giuseppe Cataldis 39-0892-50-935
Ospedale La Maddalena - Palermo *Recruiting*
Palermo, ,
Italy
Recruiting Vittorio Gebbia 39-091-680-6111
Azienda Ospedaliena G. Rummo *Recruiting*
Benevento, , 82100
Italy
Recruiting Giovanni Ianniello 0039-824-57720
Ospedale Vincenzo Monaldi *Recruiting*
Napoli, , 80131
Italy
Recruiting Alfonso Illiano 39-081-706-1111
Ospedale San Carlo *Recruiting*
Potenza, , 85100
Italy
Recruiting Luigi Manzione 39-0971-611-111
Ospedale Civile Cosenza *Recruiting*
Cosenza, , 87100
Italy
Recruiting Santi Barbera 39-0984-6811
Ospedale de Noale *Recruiting*
Noale, , 30033
Italy
Recruiting Orazio Vinante 39-041-589-6221
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Naples, , 80131
Italy
Recruiting Cesare Gridelli 39-081-590-3637
Additional Information:
Study ID Numbers: CDR0000068702; EU-20103,ITA-INTN-DISTAL
Study Start Date:
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022022
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
2. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
3. Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
4. ZD1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Napoli Clinical Trials
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
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