Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer
This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed[Alimta™], Bevacizumab and Erlotinib[Tarceva™]) which are given every 28 days.
Non-small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC)|
- Progression Free Survival (PFS) [ Time Frame: 26 months ] [ Designated as safety issue: No ]The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.
- One-year Survival(1-year S) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.
- Number of Patients Who Responded to Treatment [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD.
- Quality of Life (QOL) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
The Scales we were intending to use were:
Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).
Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).
Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).
Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).
Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed.
- Number of Participants With Grade 3 and Grade 4 Adverse Events [ Time Frame: 26 Months ] [ Designated as safety issue: Yes ]By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.
- Overall Survival (Median Survival [MS]) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.
|Study Start Date:||July 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab, Erlotinib, Pemetrexed
Single Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.
Other Name: AvastinDrug: Erlotinib
Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days.
Other Name: TarcevaDrug: Pemetrexed
Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.
Other Name: Alimta
This is a Phase I/II trial of elderly patients (> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled.
Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day 15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days.
All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351039
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||George Simon, MD||H. Lee Moffitt Cancer Center and Research Institute|