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

NCT03110484 | Unknown Phase 2 FDA Drug

• 1 other identifier: 2020-06-111
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate

  18MONTHS

Study Arms (1)

Pemetrexed+Tarceva

EXPERIMENTAL

D1 Pemetrexed 500 mg/m2 IV+ D1-21 Erlotinib 100mg once daily

Drug: Pemetrexed 500 MG; Drug: Erlotinib

Interventions

Pemetrexed 500 MG DRUG

Pemetrexed 500 mg/m2

Pemetrexed+Tarceva

Erlotinib DRUG

Erlotinib 100mg once daily

Pemetrexed+Tarceva

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Pemetrexed; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quinazolines

Study Officials

• seungtea kim

  SamsungMedicalCenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

seungtea kim, M.D. Ph.D

CONTACT

82-2-2148-7394; seungtae1.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: July 9, 2021
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (2)