NCT03086538

Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy

Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is single center single arm prospective phase II study. In this study, efficacy and side effects of pemetrexed as salvage regimen on patients who failed all standard chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until disease progression is happened.

Detailed description

Antitumor effect of pemetrexed is already proven lung cancer, pleural mesothelioma, peritoneal mesothelioma and has been used as a standard therapeutic agent. In addition, this drug does not have severe side effects, pemetrexed is thought to be an important option for patients with poor performance status or elderly patients. Pemetrexed has been studied in colorectal cancer, Zhang et al have demonstrated that pemetrexed combined with gefitinib has a significantly synergistic effect on colorectal cancer cells (17). In two phase II studies in which patients received pemetrexed as first-line treatment for metastatic disease, objective response rates were 15 - 17 %. These trials were conducted prior to supplementation with folic acid and vitamin B12, which markedly decreased the frequency of hematologic toxicities of pemetrexed; routine supplementation is now included in all clinical trials of the agent (18). Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Erlotinib showed the effect in the maintanence therapy (combined with bevacizumab) in colorector cancer. Also, erolitinib had the effect in biliary tract cancer and pancreatic cancer. Our previous phase III trial for tarceva puls GEMOX (gemcitabine plus oxaliplatin) reported that adding to tarceva to GEMOX had more useful in the specific subgroup with EFGR overexpressed patients. The aim of present study is to assess treatment efficacy and side effects of pemetrexed plus tarceva on EGFR overexpressed patients with refractory colorectal cancer and no treatment option whose performance status is relatively preserved. \<Pre-medication for Alimta\> D-7 \~ Folic acid 1mg QD PO D-7 \~ Vitamin B12 1mg/9weeks IM D-1, D1, D2 Dexamethasone 4mg BID PO \<Treatment\> D1 Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed is a multitarget antifolate (MTA) whose mechanism of action relies mainly on the inhibition of TS, with weaker secondary effects on glycinamide ribonucleotide formyltransferase (GARFT) and dihydrofolate reductase (DHFR), leading to impairment of DNA synthesis and repair.
DRUG	Tarceva 100Mg Tablet	Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Timeline

• Start date: 2017-05-30
• Primary completion: 2020-01-30
• Completion: 2020-05-25
• First posted: 2017-03-22
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea