NCT03714555

Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine

A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 2 Pilot study to evaluate Disulfiram + Copper Gluconate in patients metastatic pancreatic cancer whose CA-19-9 levels rise while receiving nab-paclitaxel (Abraxane) plus gemcitabine (Gemzar) or FOLFIRINOX or single-agent gemcitabine (Gemzar). Patient must have received a minimum of 8 weeks of treatment and have rising CA-19-9 levels in the absence of radiographic evidence of progression.

Detailed description

This study has 3 arms with 5 patients enrolled in each of the three arms. The three treatment arms are based upon whether the patient has previously received Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression for a minimum of 8 weeks , based on the investigator's opinion, but with a rising Carbohydrate antigen 19-9 (CA 19-9) levels. Rising CA 19-9 is defined as an increased over baseline of \> 20% in two consecutive time points within 8 days of each other. Study sites will provide all chemotherapy for patients participating in the study as a "standard of care". DSF/Cu (Disulfiram + Copper Gluconate) will be provided by the Sponsor and shipped from the Sponsor's central depot to the study sites. Sufficient amounts of DSF/Cu will be available at the study site prior to enrolling patients in the study.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Safety Laboratories	Complete blood cell count (CBC) w Differential, comprehensive metabolic panel (CMP), Prothrombin time/international normalized ratio (PT/INR) Activated Partial Thromboplastin Time (aPTT), Urinalysis
OTHER	AE Assessment	Assessment of Adverse Events (AE)
OTHER	Physical Exam	Physical Exam, Weight, Vital Signs, Eastern Cooperative Oncology Group (ECOG) Performance Status
OTHER	Concomitant Medication Review	Prior and Concomitant Medication Review
DIAGNOSTIC_TEST	Tumor Imaging	Tumor CT or MRI
DRUG	nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate	nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
DRUG	FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate	FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
DRUG	Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate	Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing

Timeline

• Start date: 2019-10-17
• Primary completion: 2020-07-22
• Completion: 2020-07-29
• First posted: 2018-10-22
• Last updated: 2023-10-18
• Results posted: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study