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2019-10-17
2020-07-22
2020-07-29
1
NCT03714555
HonorHealth Research Institute
HonorHealth Research Institute
INTERVENTIONAL
Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-10-09 | 2023-08-24 | 2023-09-26 |
2018-10-18 | 2023-09-26 | 2023-10-18 |
2018-10-22 | 2023-10-18 | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Nab-Paclitaxel/Gemcitabine + DSF/Cu Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatmen | DIAGNOSTIC_TEST: Safety Laboratories
OTHER: AE Assessment
OTHER: Physical Exam
OTHER: Concomitant Medication Review
DIAGNOSTIC_TEST: Tumor Imaging
DRUG: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate
DRUG: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate
DRUG: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate
|
| ACTIVE_COMPARATOR: FOLFIRINOX +DSF/Cu Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addit | DIAGNOSTIC_TEST: Safety Laboratories
OTHER: AE Assessment
OTHER: Physical Exam
OTHER: Concomitant Medication Review
DIAGNOSTIC_TEST: Tumor Imaging
DRUG: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate
DRUG: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate
DRUG: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate
|
| ACTIVE_COMPARATOR: Single-Agent Gemcitabine +DSF/Cu Subjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatm | DIAGNOSTIC_TEST: Safety Laboratories
OTHER: AE Assessment
OTHER: Physical Exam
OTHER: Concomitant Medication Review
DIAGNOSTIC_TEST: Tumor Imaging
DRUG: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate
DRUG: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate
DRUG: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| CA19-9 Plasma Level | Change in plasma CA19-9 level (at least 30%) from baseline | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Complete Tumor Response | Complete response rate as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Partial Response | Partial response as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Stable Disease | Complete response as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Response Rate | Overall response rate as defined by CT scan using RECIST 1.1 criteria | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Survival | The length of time from the start of treatment that patients are still alive | From date of enrollment until date of death assessed up to 100 months |
| Serum Albumin | Change in serum albumin level as a result of treatment | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Body Weight | Change in body weight as a result of treatment | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Muscle Area at the L3 Level - Optional | Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Incidence of Toxicities | Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0 | From date of enrollment until the date of follow-up, 30 days after last treatment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
