- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022022
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
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: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Bari, Italy, 70126
- Istituto Di Ricovero E Cura A Carattere Scientifico
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Benevento, Italy, 82100
- Azienda Ospedaliena G. Rummo
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Campobasso, Italy
- Ospedale Cardarelli - Campobasso
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Cosenza, Italy, 87100
- Ospedale Civile Cosenza
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Milan, Italy, 20157
- Ospedale Luigi Sacco
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Milan, Italy, 20153
- Ospedale San Giuseppe
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Milano, Italy, 20142
- Ospedale San Paolo
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Naples, Italy, 80131
- Federico II University Medical School
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Naples, Italy, 80131
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
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Naples, Italy, 80131
- Ospedale Vincenzo Monaldi
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Naples, Italy, 80133
- Seconda Universita di Napoli
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Noale, Italy
- Ospedale Civile P.F. Calvi
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Palermo, Italy
- Ospedale La Maddalena - Palermo
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Palermo, Italy, 90127
- Azienda Ospedaliera Policlinico Paolo Giaccone
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Potenza, Italy, 85100
- Ospedale San Carlo
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Salerno, Italy
- Ospedale da Procida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Time to progression
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Response rate
|
Quality of life
|
Survival
|
Collaborators and Investigators
Investigators
- Study Chair: Cesare Gridelli, MD, Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
Publications and helpful links
General Publications
- Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251.
- Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- CDR0000068702
- ITA-INTN-DISTAL
- EU-20103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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