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

  • End date
    Jun 14, 2024
  • participants needed
  • sponsor
    Samsung Medical Center
Updated on 28 June 2022


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


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

Condition Biliary Tract Cancer
Treatment Erlotinib, Pemetrexed 500 MG
Clinical Study IdentifierNCT03110484
SponsorSamsung Medical Center
Last Modified on28 June 2022


Yes No Not Sure

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 criteria Expected life expectancy ≥ 3months Adequate marrow, hepatic, renal and cardiac

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
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