Clinical trial NCT00350792: Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Official title: A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 62
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
timeFrame: baseline to measured objective tumor response (up to six 21-day cycles)
Secondary outcomes:
measure: Time to Treatment Failure
timeFrame: baseline to stopping treatment (up to six 21-day cycles)
measure: Overall Survival
timeFrame: baseline to date of death from any cause (up to 14.5 months)
measure: Estimated Probability of One Year Progression-free Survival
timeFrame: baseline to measured progressive disease or death, 1 year
Other outcomes:
measure: Time to Treatment Failure
timeFrame: baseline to stopping treatment (up to six 21-day cycles)
Locations:
city: Bobigny
country: France
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: Brest
country: France
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: Caen
country: France
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: Le Mans
country: France
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: Lille
country: France
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: Nantes
country: France
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: Vandoeuvre Les Nancy
country: France
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: 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: