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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086538
Recruitment Status : Unknown
Verified December 2019 by Seung tae Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Seung tae Kim, Samsung Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Drug: Pemetrexed Drug: Tarceva 100Mg Tablet Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed+Tarceva
Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086538


Contacts
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Contact: SeungTae Kim, MD, Ph.D 82-2-3410-6820 seungtae1.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: seungtae kim, MD,PhD         
Sponsors and Collaborators
Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seung tae Kim, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03086538    
Other Study ID Numbers: 2016-12-046
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Pemetrexed
Erlotinib Hydrochloride
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors