Clinical trial NCT00356525: Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Objective Tumor Response
timeFrame: baseline to time of response (up to 17.5 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: baseline to trial termination (17.5 months)
measure: Time to Progressive Disease
timeFrame: baseline to measured progressive disease (up to 17.5 months)
measure: Duration of Response
timeFrame: time of response to progressive disease (up to 17.5 months)
measure: Time to Treatment Failure
timeFrame: baseline to stopping treatment (up to 17.5 months)
Other outcomes:
Locations:
city: Miami
country: United States
facility: 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.
state: Florida
city: Evanston
country: United States
facility: 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.
state: Illinois
city: Wichita
country: United States
facility: 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.
state: Kansas
city: Minneapolis
country: United States
facility: 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.
state: Minnesota
city: Saint Louis
country: United States
facility: 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.
state: Missouri
city: Omaha
country: United States
facility: 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.
state: Nebraska
city: Chapel Hill
country: United States
facility: 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.
state: North Carolina
city: Chattanooga
country: United States
facility: 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.
state: Tennessee
city: Memphis
country: United States
facility: 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.
state: Tennessee
city: Nashville
country: United States
facility: 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.
state: Tennessee
city: Houston
country: United States
facility: 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.
state: Texas
city: Caxias Do Sul
country: Brazil
facility: 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.
city: Porto Alegre
country: Brazil
facility: 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.
city: Santo Andre
country: Brazil
facility: 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.
city: Bangalore
country: India
facility: 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.
city: Mumbai
country: India
facility: 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.
city: Trivandrum
country: India
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: