Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor - Full Text View

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

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: LY231514 Alimta Drug: gemcitabine 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Other Names: LY188011 Gemzar
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: LY231514 Alimta
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: LY231514 Alimta
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: LY231514 Alimta Drug: gemcitabine 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Other Names: LY188011 Gemzar

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site


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 Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed Carboplatin	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016