Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer

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Brief Title

Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer

Official Title

Vitamin D Receptor Agonist Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer

Brief Summary

      This research study is a two stage study which consists of a safety run-in phase and a
      randomized phase 2 study which include subjects with previously-untreated, metastatic
      pancreatic adenocarcinoma. In the run-in safety study, the safety of adding two formulations
      (IV or Oral) of paricalcitol to a standard chemotherapy program of gemcitabine and
      nab-paclitaxel will be evaluated. The randomized phase 2 study will evaluate the efficacy of
      paricalcitol when added to gemcitabine and nab-paclitaxel

      The drugs involved in this study are:

        -  Paricalcitol

        -  Gemcitabine

        -  Nab-paclitaxel
    

Detailed Description

      Pancreatic cancer is an aggressive disease with treatment options associated with modest
      benefit, therefore, new treatment options are needed. Paricalcitol is a man-made form of
      vitamin D. It is thought to work by blocking a signal in the cancer tumor cells that leads to
      growth and spreading of the tumor. Paricalcitol was approved by the Food and Drug
      Administration (FDA) for the prevention and treatment of elevated calcium levels associated
      with chronic renal failure. The FDA has not approved paricalcitol as a treatment for
      pancreatic cancer. This research study is being performed to evaluate the benefit of
      paricalcitol in combination with gemcitabine and nab-paclitaxel for this disease.

      The FDA (the U.S. Food and Drug Administration) has approved the combination of gemcitabine
      and nab-paclitaxel as a treatment option for this disease.

      Treatment will consists of 4 week treatment cycles. Paricalcitol in the oral formulation will
      be taken daily, in the intravenous formulation will be administered three times a week.
      Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.

      Subjects continue in the study until disease progression, adverse event/toxicity, death or
      either the subject or sponsor discontinues the study.

      In this research study, the main objectives include:

        -  Assess adverse side effects associated with the combination of paricalcitol with
           gemcitabine and nab-paclitaxel.

        -  Evaluate overall survival in patients with pancreatic cancer receiving gemcitabine and
           nab-paclitaxel with or without paricalcitol.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Assess adverse events (per CTCAE v4.0 criteria)

Secondary Outcome

 Assess adverse events (per CTCAE v4.0 criteria)

Condition

Pancreatic Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitabine + Nab-paclitaxel + Placebo
Description:  Gemcitabine and Nab-paclitaxel is administered intravenously 3 times a cycle.
Placebo is administered orally on a daily basis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

112

Start Date

December 5, 2018

Completion Date

November 30, 2025

Primary Completion Date

November 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma
             that is metastatic to distant sites.

          -  Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
             Patients with locally advanced, unresectable disease without distant metastases are
             excluded.

          -  No prior chemotherapy for locally advanced or metastatic pancreatic cancer.

          -  Patients are eligible if they received adjuvant treatment after surgical resection
             with single-agent gemcitabine or gemcitabine plus capecitabine or
             5-fluorouracil/leucovorin that was completed >12 months before enrollment. Similarly,
             adjuvant radiation +/- chemosensitization with 5-fluorouracil, capecitabine, or
             gemcitabine is allowed if completed >12 months before enrollment.

          -  Participants 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, MRI, or calipers by clinical exam. See
             Section 11 for the evaluation of measurable disease.

          -  Age greater than or equal to 18 years.

          -  Patients must have completed any major surgery or open biopsy ≥4 weeks from start of
             treatment.

          -  ECOG performance status ≤1 (see Appendix A)

          -  Participants must have normal organ and marrow function as defined below:

               -  Absolute neutrophil count ≥1,500/mcL

               -  Platelets ≥100,000/mcL

               -  Total bilirubin ≤1.5 × institutional upper limit of normal

               -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

               -  Calcium (corrected for albumin) * ≤1 × institutional upper limit of normal

               -  Creatinine ≤1.5 × institutional upper limit of normal OR

               -  Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels
                  above 1.5 × upper limit of normal.

               -  Corrected Calcium = serum calcium (mg/dL) + 0.8 (4 - serum albumin (g/dL))

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Negative pregnancy testing for women of child bearing age

          -  The effects of Paricalcitol, Gemcitabine and nab-Paclitaxel on the developing human
             fetus are unknown. For this reason and because vitamin D receptor agonist agents as
             well as other therapeutic agents used in this trial are known to be teratogenic, women
             of child-bearing potential and men must agree to use adequate contraception (hormonal
             or barrier method of birth control; abstinence) prior to study entry and for the
             duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she should inform
             her treating physician immediately. Men treated or enrolled on this protocol must also
             agree to use adequate contraception prior to the study, for the duration of study
             participation, and 4 months after completion of treatment administration

        Exclusion Criteria:

          -  Prior chemotherapy or any other investigational agents for the treatment of locally
             advanced or metastatic pancreatic cancer

          -  Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted
             therapy, immunotherapy, or biological agents.

          -  Participants with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to paricalcitol, gemcitabine or nab-paclitaxel

          -  Pre-existing hypercalcemia, defined as baseline serum calcium (corrected for albumin)
             above the institutional upper limit of normal.

          -  At the time of trial enrollment, vitamin D containing supplements must be stopped and
             no vitamin D supplements can be taken while the patient is enrolled to the study due
             to increased risk for hypercalcemia

          -  At the time of trial enrollment, calcium containing supplements must be stopped and no
             calcium supplements can be taken while the patient is enrolled to the study due to
             increased risk for hypercalcemia

          -  History of symptomatic genitourinary stones (e.g. kidney stones) within the past 12
             months

          -  History of prior or current synchronous malignancy, except:

               -  Malignancy that was treated with curative intent and for which there has been no
                  known active disease for >3 years prior to enrollment

               -  Curatively treated non-melanoma skin cancer, cervical cancer in situ, or
                  prostatic intraepithelial neoplasia, without evidence of prostate cancer

          -  Pre-existing, clinically significant peripheral neuropathy, defined as CTCAE grade 2
             or higher neurosensory or neuromotor toxicity, regardless of etiology

          -  Regular use of thiazide diuretics (e.g. hydrochlorothiazide), which can lead to
             hypercalcemia. Patients must stop these diuretics prior to initiating treatment. Other
             anti-hypertensive medications can be substituted, as needed.

          -  Participants receiving any medications or substances that are inhibitors or inducers
             of CYP450 3A enzyme(s) are ineligible. Because the lists of these agents are
             constantly changing, it is important to regularly consult a frequently-updated list
             such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts
             such as the Physicians' Desk Reference may also provide this information. As part of
             the enrollment/informed consent procedures, the patient will be counseled on the risk
             of interactions with other agents, and what to do if new medications need to be
             prescribed or if the patient is considering a new over-the-counter medicine or herbal
             product. [see Appendix D]

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Participant must be able to swallow and absorb pills.

          -  Pregnant women are excluded from this study because Paricalcitol is a vitamin D
             receptor agonist agent with the potential for teratogenic or abortifacient effects.
             Because there is an unknown but potential risk for adverse events in nursing infants
             secondary to treatment of the mother with Paricalcitol, breastfeeding should be
             discontinued if the mother is treated with Paricalcitol. These potential risks may
             also apply to other agents used in this study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kimberly Perez, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03520790

Organization ID

18-021


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Stand Up To Cancer

Study Sponsor

Kimberly Perez, MD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

January 2020