Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350792
• Other study ID #: 9941
• Secondary ID: H3E-FP-S099
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2006
• Last updated: October 11, 2010
• Start date: August 2006
• Est. completion date: November 2009

Study information

• Verified date: October 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV

• No previous chemotherapy for lung cancer

• Men and women > or = 70 years

• At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

Exclusion Criteria:

• Treatment within the last 30 days with a drug that has not received regulatory approval

• Serious systemic disorders

• Inability to discontinue administration of aspirin or anti-inflammatory non steroid

• Concurrent administration of any other antitumor therapy

• Brain metastasis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• pemetrexed
500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles
• carboplatin
Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Locations

Country	Name	City	State
France	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.	Bobigny
France	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.	Brest
France	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.	Caen
France	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.	Le Mans
France	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.	Lille
France	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.	Nantes
France	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.	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)	Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.	baseline to measured objective tumor response (up to six 21-day cycles)	No
Secondary	Time to Treatment Failure	Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.	baseline to stopping treatment (up to six 21-day cycles)	Yes
Secondary	Overall Survival	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.	baseline to date of death from any cause (up to 14.5 months)	No
Secondary	Estimated Probability of One Year Progression-free Survival	Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.	baseline to measured progressive disease or death, 1 year	No