Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191620
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
The purposes of this study are to determine:
How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.
The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Carcinoma |
Drug: Gemcitabine Drug: cisplatin |
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: | Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion.
Secondary Outcome Measures:
- To evaluate progression-free survival of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for advanced NSCLC.
- To evaluate incidence of laboratory and non laboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 18 years of age
- Histologically or cytologically confirmed diagnosis of NSCLC
- Have provided written informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
- Presence of uncontrolled central nervous system (CNS) metastases
- Inability to comply with protocol or study procedures
- Pregnancy
- Breast feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191620
Locations
| Argentina | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician | |
| Buenos Aires, Argentina | |
| Brazil | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician | |
| Sao Paulo, Brazil | |
| Chile | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician | |
| Santiago, Chile | |
| Mexico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/ GMT - 5 hours, EST), or speak with your personal physician | |
| Mexico City, Mexico | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/ GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00191620 History of Changes |
| Other Study ID Numbers: | 6952, B9E-LA-S350 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | Mexico: Federal Commission for Protection Against Health Risks Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Chile: Instituto de Salud Publica de Chile Brazil: National Health Surveillance Agency |
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 Gemcitabine |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013