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Updated: May 8, 2026
Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Phase I/II trial of pemetrexed plus nab-paclitaxel in advanced solid tumor patients with emphasis on non-small cell
Cheryl Ho1, Angela M Davies, Randeep S Sangha
1British Columbia Cancer Agency, 600 W 10th Avenue, Vancouver, BC, V5Z 4E6, Canada, cho@bccancer.bc.ca.
Background:
Despite advances in targeted therapies, there is an ongoing need to develop new and effective cytotoxic drug combinations in non-small cell lung cancer (NSCLC). Based on preclinical demonstration of additive cytotoxicity, we evaluated the safety and efficacy of combining pemetrexed and nanoparticle albumin bound (nab) paclitaxel with a focus on NSCLC for phase II expansion.
Methods:
A 3 + 3 dose-escalation design was used to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Three dose levels were tested: pemetrexed 500 mg/m(2) day 1 and nab-paclitaxel day 1 at 180, 220, & 260 mg/m(2) every 21 days. Phase II eligibility included advanced NSCLC, ≤2 line prior therapy, PS 0-1, adequate organ function. Primary endpoint for further study was response rate (RR) ≥ 25%.
Results:
Planned dose escalation was completed without reaching the MTD. The RP2D was pemetrexed 500 mg/m(2) and nab-paclitaxel 260 mg/m(2). The phase II portion accrued 37 pts before early closure due to increasing first-line pemetrexed/platinum doublet use in non-squamous NSCLC. In 31 assessable phase II patients there were 5 partial responses, 12 stable disease, 14 progressive disease. The median overall survival was 8.8 months; progressive disease 4.4 months and disease control 15.6 months.
Conclusions:
Pemetrexed 500 mg/m(2) day 1 with nab-paclitaxel 260 mg/m(2) was feasible and well tolerated. The phase II component demonstrated activity in second/third-line therapy of advanced NSCLC; response rate 14% and disease control rate 46%. Treatment practice patterns of advanced NSCLC have evolved; further trials of this regimen are not planned.
Insights
This study combined pemetrexed and nanoparticle albumin-bound paclitaxel for non-small cell lung cancer (NSCLC). The regimen was safe and showed activity in later lines of therapy, though further trials are not planned due to evolving treatment standards.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- There is a continuous need for novel cytotoxic drug combinations in non-small cell lung cancer (NSCLC) despite advances in targeted therapies.
- Preclinical data suggested additive cytotoxicity for pemetrexed and nanoparticle albumin-bound (nab) paclitaxel.
Purpose of the Study:
- To evaluate the safety and efficacy of combining pemetrexed and nab-paclitaxel in advanced non-small cell lung cancer (NSCLC).
- To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for this combination regimen.
Main Methods:
- A 3+3 dose-escalation design was employed to identify the MTD and RP2D.
- Pemetrexed (500 mg/m²) was combined with nab-paclitaxel (180, 220, or 260 mg/m²) administered every 21 days.
- Phase II eligibility criteria included advanced NSCLC with limited prior therapy and adequate organ function.
Main Results:
- The MTD was not reached; the RP2D was established as pemetrexed 500 mg/m² and nab-paclitaxel 260 mg/m².
- The phase II portion enrolled 37 patients, with 31 assessable for response. Observed responses included 5 partial responses and 12 cases of stable disease.
- Median overall survival was 8.8 months, with disease control lasting a median of 15.6 months in patients with progressive disease.
Conclusions:
- The combination of pemetrexed 500 mg/m² and nab-paclitaxel 260 mg/m² was found to be feasible and well-tolerated in advanced NSCLC.
- The regimen demonstrated activity in second/third-line settings, achieving a 14% response rate and 46% disease control rate.
- Further clinical trials of this specific regimen are not planned due to shifts in standard treatment paradigms for advanced NSCLC.
