Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies

PHASE1RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 8, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

May 31, 2027

Conditions
Pancreatic AdenocarcinomaGastroesophageal Junction AdenocarcinomaAdenocarcinoma
Interventions
DRUG

Oxaliplatin

Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG

Docetaxel

Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG

Leucovorin

Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG

Irinotecan

Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG

5-Fluorouracil

5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.

Trial Locations (1)

60637

RECRUITING

The University of Chicago, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER

NCT04361708 - Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies | Biotech Hunter | Biotech Hunter