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Pemetrexed in Combination With Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer (BTC) Who Failed Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03110484
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : November 23, 2020
Information provided by (Responsible Party):
Seung tae Kim, Samsung Medical Center

Brief Summary:
Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic biliary tract cancer (BTC) who failed gemcitabine containing chemotherapy

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Pemetrexed 500 MG Drug: Erlotinib Phase 2

Detailed Description:

Biliary tract carcinoma (BTC) is rare in the Europe and the United States, but not uncommon in Asia and Latin America. The tumor arises from the ductular epithelium of the biliary tree within the liver (intrahepatic), the extrahepatic ducts (extrahepatic), or the gallbladder. Intrahepatic cancer is steadily increasing in the Western world. BTCs carry a poor prognosis with 1-year survival rate of 25%. Although surgery remains the only curative treatment for BTC, most patients present with advanced disease and die within a few months of diagnosis. While a combination of gemcitabine and platinum agents seems to be a conclusive treatment option as first-line treatment until now, the role or the optimal regimen for second-line treatment has not been established.

Pemetrexed, a multitarget antifolate which inhibits thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyltransferase, was approved for the treatment of lung cancer and mesothelioma. In addition to its therapeutic efficacy, pemetrexed has tolerable safety profile and is considered as important therapeutic option for patients of poor performance statue or older age. Pemetrexed was studied in combination with gemcitabine in BTC patients and needs further research in BTC patients. Erlotinib is EGFR tyrosine kinase inhibitor. In BTC and pancreatic cancer, erlotinib showed prolonged survival in combination with chemotherapy. Moreover, the addition of erlotinib to gemcitabine and oxaliplatin showed antitumour activity in our previous phase III trial. And combination of pemetrexed and erlotinib showed tolerable safety profile in lung cancer trial.

So we plan this study to evaluate the efficacy and safety of pemetrexed in combination with erlotinib as a second line treatment in biliary tract cancer

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: Pemetrexed+Tarceva
D1 Pemetrexed 500 mg/m2 IV+ D1-21 Erlotinib 100mg once daily
Drug: Pemetrexed 500 MG
Pemetrexed 500 mg/m2

Drug: Erlotinib
Erlotinib 100mg once daily

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 18MONTHS ]
    Overall response rate

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

Inclusion Criteria:

Provision of a signed written informed consent Age ≥ 20 Histologically or cytologically confirmed carcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer) Unresectable or metastatic Progression after treatment with first line gemcitabine-based chemotherapy ECOG performance status of 0~2 Measurable lesion per RECIST 1.1 criteria Expected life expectancy ≥ 3months Adequate marrow, hepatic, renal and cardiac functions

Exclusion Criteria:

Poor performance statue Other primary cancer except properly treated non-melanoma skin cancer, cured cervix carcinoma in situ and other cured solid tumor without evidence of recurrence after 5 years of curative treatment.

Severe co-morbid illness and/or active infections Any other clinical trial therapeutics within 14 days Any anti-cancer therapy within 3 weeks prior to initiation of study treatment (radiotherapy, systemic chemotherapy) CTCAE grade 2 or more adverse events remained except alopecia QTcB > 480msec or family history of QT prolongation Current heart problem such as: pooly controlled hypertension

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 identifier (NCT number): NCT03110484

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Contact: seungtea kim, M.D. Ph.D 82-2-2148-7394

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Contact: seungtae Kim, M.D., Ph.D    82 2 3410 0297   
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: seungtea kim SamsungMedicalCenter
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Responsible Party: Seung tae Kim, Samsung Medical Center Identifier: NCT03110484    
Other Study ID Numbers: 2020-06-111
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020

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