Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193414
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Pemetrexed Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Secondary Outcome Measures:
- Progression-free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
- Overall Survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]OS was measured from the date of study entry until the date of death.
| Enrollment: | 74 |
| Study Start Date: | May 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
Drug: Pemetrexed
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
Other Name: Alimta
Drug: Gemcitabine
1500mg/m2, 30min IV
Other Name: Gemzar
|
Detailed Description:
Upon determination of eligibility, patients will be receive:
- Pemetrexed + Gemcitabine
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Histologically confirmed non-small cell bronchogenic carcinoma
- Newly diagnosed or recurrent unresectable stage III or stage IV disease
- No mixed tumors with small cell anaplastic elements
- Measurable disease
- Must not have received any prior antineoplastic chemotherapy for lung cancer
- Age > 18 years
- Able to perform activities of daily living with little or no assistance
- Adequate bone marrow, liver and kidney
- Understand the nature of this study and give written informed consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Female patients who are pregnant or are lactating
- History of serious cardiovascular disease within the previous six months
- Serious active infection at the time of treatment
- Other serious underlying medical condition
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193414
Locations
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Sarah Cannon Research Institute
Eli Lilly and Company
Investigators
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193414 History of Changes |
| Other Study ID Numbers: | SCRI LUN 91, H3E-US-X011 |
| Study First Received: | September 12, 2005 |
| Results First Received: | October 11, 2012 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013