Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 46 for:    disulfiram

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714555
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Cantex Pharmaceuticals
Information provided by (Responsible Party):
HonorHealth Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer 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 Phase 2

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 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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021


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 treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Diagnostic Test: Safety Laboratories
CBC w Differential, CMP, PT/INR, aPTT, Urinalysis

Other: AE Assessment
Assessment of Adverse Events

Other: Physical Exam
Physical Exam, Weight, Vital Signs, 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

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 addition of Disulfiram+Copper Gluconate until disease progression.
Diagnostic Test: Safety Laboratories
CBC w Differential, CMP, PT/INR, aPTT, Urinalysis

Other: AE Assessment
Assessment of Adverse Events

Other: Physical Exam
Physical Exam, Weight, Vital Signs, 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

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 treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Diagnostic Test: Safety Laboratories
CBC w Differential, CMP, PT/INR, aPTT, Urinalysis

Other: AE Assessment
Assessment of Adverse Events

Other: Physical Exam
Physical Exam, Weight, Vital Signs, 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




Primary Outcome Measures :
  1. CA19-9 Plasma Level [ Time Frame: 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 ]
    Change in plasma CA19-9 level (at least 30%) from baseline


Secondary Outcome Measures :
  1. Complete Tumor Response [ Time Frame: 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 ]
    Complete response rate as defined by CT scan using RECIST 1.1 criteria

  2. Partial Response [ Time Frame: 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 as defined by CT scan using RECIST 1.1 criteria

  3. Stable Disease [ Time Frame: 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 ]
    Complete response as defined by CT scan using RECIST 1.1 criteria

  4. Overall Response Rate [ Time Frame: 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 as defined by CT scan using RECIST 1.1 criteria

  5. Overall Survival [ Time Frame: From date of enrollment until date of death assessed up to 100 months ]
    The length of time from the start of treatment that patients are still alive

  6. Serum Albumin [ Time Frame: 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 ]
    Change in serum albumin level as a result of treatment

  7. Body Weight [ Time Frame: 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 ]
    Change in body weight as a result of treatment

  8. Muscle Area at the L3 Level - Optional [ Time Frame: 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 ]
    Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan

  9. Incidence of Toxicities [ Time Frame: From date of enrollment until the date of follow-up, 30 days after last treatment ]
    Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0


Other Outcome Measures:
  1. Disulfiram/Copper Gluconate Serum Levels - Area Under the Curve (AUC) [ Time Frame: Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7 ]
    Optional Day 0 (pre-Cycle 1 Day 1) at pre-dose, 2 hours, 4 hours, 24 hours and 4 hours post-dose Cycle 1 Day 7



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically confirmed adenocarcinoma of the pancreas that is metastatic and for which potential curative measures, such as resection of an isolated metastasis, are not available. Patients with islet cell neoplasms are excluded.
  2. Patient should currently be receiving a chemotherapy regimen comprising FOLFIRINOX or Abraxane-Gemcitabine or single-agent Gemcitabine as front-line treatment for metastatic disease. Patients who have had chemotherapy in the adjuvant or neoadjuvant setting are eligible.
  3. Patients must have previously received a minimum of 8 weeks of therapy with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression based on the investigator's opinion, but a rising CA 19-9 level, and still be undergoing treatment with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine. Increased CA 19-9 is defined as an increased over baseline of > 20% in two consecutive time points within 8 days of each other.
  4. Patient has one or more metastatic tumors measurable by CT scan. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  5. Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
  6. Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL.
  7. Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:

    • AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 × ULN is allowed. Total bilirubin ≤ 1.5 × ULN.
    • Serum creatinine < 1.5X ULN or estimated creatinine clearance of > 60 mL/min (per Cockroft-Gault formula)
  8. Patient has ECOG performance status from 0 to ≤ 1.
  9. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria:

  1. Patient has brain metastases.
  2. Patient has experienced an increase of ECOG to > 1 between Screening and enrollment.
  3. QTc > 480 msec if patient receiving oxaliplatin-containing regimen.
  4. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  5. Patient has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class or any of their excipients. The patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of Gemcitabine or Abraxane ® Prescribing Information package inserts or on the Investigator's Brochure for DSF/Cu.
  6. Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
  7. Patient is enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
  8. Patient is unwilling or unable to comply with study procedures.
  9. Abraxane is metabolized by CYP2C8 and CYP3A4. Co-administration of substrates, inhibitors of CYP2C8 (see Appendix C) and/or CYP3A4 (see Appendix D) with Abraxane is not allowed. The following medications and substances are not allowed during the study: ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efiravenz, or nerivapine, grapefruit (juice or seeds) or some herbals like St. John's wort.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714555


Contacts
Layout table for location contacts
Contact: Joyce Schaffer, RN 480-323-1339 clinicaltrials@honorhealth.com

Sponsors and Collaborators
HonorHealth Research Institute
Cantex Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Gayle Jameson, ACNP-BC HonorHealth Research Institute

Layout table for additonal information
Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT03714555     History of Changes
Other Study ID Numbers: CAN-203
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disulfiram
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Copper
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Pancrelipase
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Trace Elements