Clinical Trials /

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

NCT03086538

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 2016-12-046
  • NCT ID: NCT03086538

Conditions

  • Colo-rectal Cancer

Interventions

DrugSynonymsArms
PemetrexedPemetrexed+Tarceva
Tarceva 100Mg TabletPemetrexed+Tarceva

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
Pemetrexed+TarcevaExperimentalPemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
  • Pemetrexed
  • Tarceva 100Mg Tablet

Eligibility Criteria

        Inclusion Criteria:

          -  Advanced colorectal cancer failed from all standard chemotherapy

               -  History of refractoriness from chemotherapy including 5-FU, Oxaliplatin,
                  Irinotecan

               -  Oral 5-FU agents are included standard chemotherapy

               -  Targeted agents such as cetuximab or bevacizumab are not included in inclusion
                  criteria

          -  Patient must have willingness and ability to comply with the study protocol including
             visiting hospital for test and treatment during trial

          -  ECOG performance status 0~2

          -  Measurable lesion (RECIST 1.1) must exist

          -  Expected survival should be more than 3 months from first dose of pemetrexed

          -  Adequate organ function as defined as below estimated 28 days before first doe of
             pemetrexed:

        Exclusion Criteria:

          -  Poor performance status (ECOG PS ≥ 3)

          -  Patient can not take folic acid or Vitamin B12.

          -  History of previous treatment with pemetrexed

          -  History of malignant disease, except: non-melanoma skin cancer that properly treated,
             cured uterine cervical cancer or other solid tumor without evidence of recurrence
             within 5 years

          -  Patient can not swallow oral pills.

          -  Treatment with medication of clinical trial within 14 days (or longer duration
             according to specific agents)

          -  Systemic chemotherapy or radiation (except palliative purpose) within 3 weeks (or
             longer duration according to specific agents)

          -  Toxicity from previous treatment as CTCAE grade > 1, except alopecia

          -  bowel obstruction or CTCAE grade 3/4 upper GI bleeding before 4 weeks

          -  QTc prolongation (QTc > 480msec) at resting is documented more than twice within 24
             hours or family history of QT prolongation syndrome
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:6 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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