Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer (ACE)
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer|
- Progression free survival [ Time Frame: The study lasts for 30 months of which subject accrual occurs in the first 24 months ] [ Designated as safety issue: Yes ]To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.
- Objective response rate, Overall survival, Safety and Quality of life [ Time Frame: The study lasts for 30 months of which subject accrual occurs in the first 24 months ] [ Designated as safety issue: Yes ]
To compare the following efficacy variables between treatment arms:
- Objective response rate
- Overall survival
- To compare the safety and adverse event profile between treatment arms
- To assess the impact of treatment on patient-rated quality of life (FACT-L)
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: PemCarbo
Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy
Other Name: Alimta: brand name of Pemetrexed
Active Comparator: Pem only
Drug: Pem only
Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.
Other Name: Alimta: brand name of pemetrexed
The treatment of NSCLC in elderly has been subject to discussion for years. While platinum doublets consisting of cisplatin or carboplatin and another cytotoxic agent demonstrate a survival advantage compared with single agents generally, evidence of treatment efficacy for patients with diminished performance status (PS) or with age older than 70 years is limited. Guidelines from the US and Europe have preferred single-agent chemotherapy for the elderly and PS 2 patients. However, increasing studies are exploring this issue and presenting data that favour doublet therapy. The addition of carboplatin to paclitaxel and cisplatin to docetaxel have shown evidence that patients over 70 benefit more in face of increased toxicities.
This study is designed to be multi-center, open-label, prospective, randomized, two-arm, parallel, phase III trial of elderly patients(≥70 years old) with metastatic non-squamous NSCLC (Stage IV by AJCC 7th) who have not received prior systemic chemotherapy or biological therapy. Approximately 266 patients will be enrolled into the trial. This study compares the doublet therapy of pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL*min) administered intravenously every 21 days for 4 cycles followed by pemetrexed (500 mg/m2) every 21 days for maintenance therapy (Arm A) to single therapy of pemetrexed (500 mg/m2) every 21 days till progression or unacceptable toxicity (Arm B). Pemetrexed will be administered with vitamin B12 and folate supplements.
|Contact: Sang-We Kim, M.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Sang-We Kim, M.D. 82-2-3010-3215 email@example.com|
|Principal Investigator:||Sang-We Kim, M.D.||Asan Medical Center|