Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00269152
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).
A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
- Must have complete tumor resection by pneumonectomy or lobectomy
- Must have been surgically proven to be N2 negative
- Serious concomitant systemic disorder
- Post-operative complications or other surgery related conditions
- A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B: Pemetrexed + Carboplatin pemetrexed - A: Pemetrexed + Cisplatin pemetrexed - A: Pemetrexed + Cisplatin cisplatin - B: Pemetrexed + Carboplatin carboplatin -
- Primary Outcome Measures
Name Time Method The Feasibility of Post-Surgery Chemotherapy every 21-day cycle for 4 cycles up to 30 days after last infusion Feasibility was measured by completion of 4 treatment cycles without remaining toxicities \>=Grade 3 at 30 days after last infusion.
- Secondary Outcome Measures
Name Time Method Grade III/IV Adverse Events every 21-day cycle for 4 cycles Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
Overall Survival at 3 Years baseline to date of death from any cause, assessed at 3 years For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years length of time disease free, assessed at 3 years For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.
Overall Survival at 6 Years Baseline to date of death from any cause assessed at 6 years For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
Trial Locations
- Locations (1)
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.
🇪🇸Santiago De Compostela, Spain