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Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer (PTCA199-5)

Primary Purpose

Pancreatic Cancer Stage IV, Chemotherapy-induced Nausea and Vomiting

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Thalidomide
Nab paclitaxel
Gemcitabine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage IV focused on measuring chemotherapy, pancreatic cancer, Thalidomide, nausea, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years and ≤ 80 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. Adequate organ performance based on laboratory blood tests. Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The expected survival ≥ 3 months. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients who have received any form of anti-tumor therapy. The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. Pregnant or nursing women. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc). History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. Patients who are unwilling or unable to comply with study procedures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Chemotherapy + Thalidomide

    Chemotherapy

    Arm Description

    nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.

    nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. .

    Outcomes

    Primary Outcome Measures

    Rate of nausea/vomiting
    Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.

    Secondary Outcome Measures

    Pain numeric rating scale (NRS)
    Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
    Quality of life (QOL)
    Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
    Sleep quality index
    Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)
    Overall survival (OS)
    OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06017284
    Brief Title
    Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
    Acronym
    PTCA199-5
    Official Title
    Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.
    Detailed Description
    Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting, insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen. Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma), graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as skin lesions). It caused severe malformations in babies born to mothers taking the drug for morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of life for patients with pancreatic cancer. The purpose of this study is to evaluate the efficacy of Thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of pain, quality of life, and overall survival are measured every four weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer Stage IV, Chemotherapy-induced Nausea and Vomiting
    Keywords
    chemotherapy, pancreatic cancer, Thalidomide, nausea, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chemotherapy + Thalidomide
    Arm Type
    Experimental
    Arm Description
    nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
    Arm Title
    Chemotherapy
    Arm Type
    Active Comparator
    Arm Description
    nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. .
    Intervention Type
    Drug
    Intervention Name(s)
    Thalidomide
    Intervention Description
    Thalidomide 100 mg/day, once a day, orally intake at night.
    Intervention Type
    Drug
    Intervention Name(s)
    Nab paclitaxel
    Intervention Description
    nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
    Primary Outcome Measure Information:
    Title
    Rate of nausea/vomiting
    Description
    Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)
    Secondary Outcome Measure Information:
    Title
    Pain numeric rating scale (NRS)
    Description
    Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)
    Title
    Quality of life (QOL)
    Description
    Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)
    Title
    Sleep quality index
    Description
    Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)
    Title
    Overall survival (OS)
    Description
    OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years and ≤ 80 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. Adequate organ performance based on laboratory blood tests. Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The expected survival ≥ 3 months. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients who have received any form of anti-tumor therapy. The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. Pregnant or nursing women. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc). History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. Patients who are unwilling or unable to comply with study procedures.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ying Yang, MD
    Phone
    86 64175590
    Ext
    1307
    Email
    yangying@fudanpci.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guopei Luo, MD
    Organizational Affiliation
    Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28854065
    Citation
    Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.
    Results Reference
    background
    PubMed Identifier
    12947072
    Citation
    Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.
    Results Reference
    background

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    Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

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