Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
This study has been terminated.
(Stopped early due to low enrollment)
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356525
First received: July 24, 2006
Last updated: August 9, 2010
Last verified: August 2010
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Purpose
The purpose of this study is to help answer:
- Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
- Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasms |
Drug: pemetrexed Drug: gemcitabine Drug: carboplatin Drug: Pemetrexed |
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: | Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy |
Resource links provided by NLM:
Drug Information available for:
Carboplatin
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Objective Tumor Response [ Time Frame: baseline to time of response (up to 17.5 months) ] [ Designated as safety issue: No ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: baseline to trial termination (17.5 months) ] [ Designated as safety issue: No ]Overall survival is the number of participants who were alive when the trial was terminated.
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: time of response to progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
- Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 17.5 months) ] [ Designated as safety issue: Yes ]
| Enrollment: | 41 |
| Study Start Date: | September 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
|
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
|
|
Experimental: Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
|
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
|
|
Experimental: One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
|
Drug: carboplatin
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
|
|
Experimental: One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
|
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
- You have good kidney, liver, and bone marrow organ function.
- You are fully active or able to carry out light work such as housework or office work.
Exclusion Criteria:
- You have received pemetrexed or gemcitabine in the past for lung cancer
- You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
- You are unable to take corticosteroid drugs like dexamethasone
- You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
- You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
- You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356525
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356525
Locations
| United States, Florida | |
| 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. | |
| Miami, Florida, United States, 33179 | |
| United States, Illinois | |
| 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. | |
| Evanston, Illinois, United States, 60201 | |
| United States, Kansas | |
| 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. | |
| Wichita, Kansas, United States, 67214 | |
| United States, Minnesota | |
| 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. | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| 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. | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| 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. | |
| Omaha, Nebraska, United States, 68114 | |
| United States, North Carolina | |
| 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. | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Tennessee | |
| 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. | |
| Chattanooga, Tennessee, United States, 37404 | |
| 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. | |
| Memphis, Tennessee, United States, 38120 | |
| 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. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| 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. | |
| Houston, Texas, United States, 77060 | |
| 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. | |
| Caxias Do Sul, Brazil, 95070560 | |
| 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. | |
| Porto Alegre, Brazil, 90430-090 | |
| 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. | |
| Santo Andre, Brazil, 09090780 | |
| India | |
| 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. | |
| Bangalore, India, 560 029 | |
| 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. | |
| Mumbai, India, 400016 | |
| 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. | |
| Trivandrum, India, 695011 | |
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
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00356525 History of Changes |
| Other Study ID Numbers: | 9934, H3E-US-S082 |
| Study First Received: | July 24, 2006 |
| Results First Received: | June 8, 2009 |
| Last Updated: | August 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin Gemcitabine Pemetrexed Anti-Infective Agents |
Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015