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
Study ID
NCT03110484
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed 500 MG — DRUG
    Pemetrexed 500 mg/m2
  • Erlotinib — DRUG
    Erlotinib 100mg once daily

Study Details

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

Key Dates

First listed
Apr 12, 2017
Start date
Jul 9, 2021
Status verified
Jun 2022
Primary completion
Jun 14, 2023
Completion
Jun 14, 2024

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed+Tarceva
    D1 Pemetrexed 500 mg/m2 IV+ D1-21 Erlotinib 100mg once daily

Primary Outcome Measure

Overall response rate [ Time Frame: 18MONTHS ]

Central Contacts

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