Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139711
First received: August 29, 2005
Last updated: March 27, 2008
Last verified: October 2006
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Purpose
A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Irinotecan Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Phase II Study Evaluating The Activity And Tolerability Of Three Different Combinations Of Docetaxel (Taxotere) And Irinotecan (Campto) As Second Line Therapy For Recurrent Or Metastatic Non Small Cell Lung Cancer (NSCLS) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Evaluate the activity and tolerability of the association of irinotecan and docetaxel according to three different schedules as second line treatment for recurrent or metastatic NSCLC.
Secondary Outcome Measures:
- Evaluate, in each arm, the time to progression, the duration of response and the survival
| Estimated Enrollment: | 138 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically proven NSCLC
- Recurrent or metastatic NCSLC
Exclusion Criteria:
- Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years
- History or presence of brain or meningeal metastases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139711
Locations
| Italy | |
| Pfizer Investigational Site | |
| Alzano Lombardo, BG, Italy, 24022 | |
| Pfizer Investigational Site | |
| Gravedona, CO, Italy, 22015 | |
| Pfizer Investigational Site | |
| Crema, CR, Italy, 26013 | |
| Pfizer Investigational Site | |
| Gorgonzola, MI, Italy, 20064 | |
| Pfizer Investigational Site | |
| Melegnano, MI, Italy, 20070 | |
| Pfizer Investigational Site | |
| Vimercate, MI, Italy, 20059 | |
| Pfizer Investigational Site | |
| Bari, Italy, 70126 | |
| Pfizer Investigational Site | |
| Benevento, Italy, 82100 | |
| Pfizer Investigational Site | |
| Borgomanero, Italy, 28021 | |
| Pfizer Investigational Site | |
| Brescia, Italy, 25123 | |
| Pfizer Investigational Site | |
| Mantova, Italy, 46100 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20133 | |
| Pfizer Investigational Site | |
| Monza, Italy, 20052 | |
| Pfizer Investigational Site | |
| Napoli, Italy, 80136 | |
| Pfizer Investigational Site | |
| Varses, Italy, 21100 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00139711 History of Changes |
| Other Study ID Numbers: | XRP6976C/2501, A5961088 |
| Study First Received: | August 29, 2005 |
| Last Updated: | March 27, 2008 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Irinotecan Docetaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013