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

Sponsor

Samsung Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03110484

Collaborator

(none)

Enrollment

Locations

Arm

35.2

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SAMSUNG MEDICAL CENTER

Actual Study Start Date :

Jul 9, 2021

Anticipated Primary Completion Date :

Jun 14, 2023

Anticipated Study Completion Date :

Jun 14, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall response rate [18MONTHS]
Overall response rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351
2	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator: seungtea kim, SamsungMedicalCenter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seung tae Kim,PhMD, Samsung Medical Center, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03110484

Other Study ID Numbers:

2020-06-111

First Posted:

Apr 12, 2017

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Pemetrexed

Erlotinib Hydrochloride

Study Results

No Results Posted as of Jun 15, 2022