Overview

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

Status:
Not yet recruiting
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
All
Summary
Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic biliary tract cancer (BTC) who failed gemcitabine containing chemotherapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Erlotinib Hydrochloride
Pemetrexed
Criteria
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