Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT02720601
Phase
PHASE2
Status
Withdrawn

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Irinotecan & Capecitabine — DRUG
    Irinotecan will be administered at infusion room over 60 minutes. Capecitabine will be administered by the patients at home. Unless there is early progression of disease, at least two courses will be administered to each patient. Repeated courses may be given to the patients who benefit from the treatment (either complete or partial remission, or stabilization of disease)

Study Details

Biliary tract cancers that progress after first line treatment can be difficult to treat. There is a great need for an effective, tolerable, easy to administer second-line regimen. Previous early phase studies demonstrated that the combination of two chemotherapy drugs, irinotecan and capecitabine had activity in this setting. The goal of this study is to determine whether this drug combination, as a second-line treatment, can improve progression free survival in patients with biliary tract cancers.

Key Dates

Start date
Nov 30, 2015
Status verified
Jan 2018
Primary completion
Mar 31, 2018
Completion
Mar 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan & Capecitabine
    Irinotecan at 120 mg/m2 intravenously every three weeks + Capecitabine at 1500 mg/m2/day orally twice per day for a total of 14 days. The treatment cycle is once every 21 days.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 6 months from the time of initiating treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Universtiy of New Mexico - Cancer CenterAlbuquerqueNew Mexico87106-

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Universtiy of New Mexico - Cancer Center· Albuquerque, NM

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