Pemetrexed and Erlotinib for Metastatic Colorectal Cancer

Sponsor
Yonsei University
Study ID
NCT02723578
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days
  • Erlotinib — DRUG
    Erlotinib 150 mg PO once daily on days 1-21 every 21 days

Study Details

Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and gefitinib in preclinical study. In this multicenter, non randomized, open label phase II study, investigators aimed to evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.

Key Dates

First listed
Mar 30, 2016
Start date
Dec 1, 2015
Status verified
Jan 2020
Primary completion
Aug 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed and Erlotinib
    Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and Erlotinib 150 mg PO once daily on days 1-21 every 21 days

Primary Outcome Measure

Overall response rate [ Time Frame: up to 2 years ]

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