Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 5, 2016

Primary Completion Date

September 30, 2019

Study Completion Date

October 16, 2020

Conditions
Pancreatic Ductal AdenocarcinomaSarcoma
Interventions
DRUG

Decitabine

"Dose escalation starting at 0.1mg/kg, subcutaneously administered on twice weekly schedule for three weeks of a 28 day cycle.~Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Level 1\*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;~\*Starting Dose Level"

DRUG

Gemcitabine

"Fixed infusion rate of 900 mg/m2, IV over 90 min, on Days, 1, 8 and 15 of a 28-day cycle.~Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Level 1\*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;~\*Starting Dose Level"

Trial Locations (1)

52242

University of Iowa Hospitals and Clinics, Iowa City

All Listed Sponsors
collaborator

Holden Comprehensive Cancer Center

OTHER

collaborator

University of Iowa

OTHER

lead

Mohammed Milhem

OTHER

NCT02959164 - Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma | Biotech Hunter | Biotech Hunter