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

November 21, 2023 updated by: Guopei Luo, Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Cancer Center
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy + Thalidomide
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.
Drug: Thalidomide
Thalidomide 100 mg/day, once a day, orally intake at night.
Drug: Nab paclitaxel
nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
Drug: Gemcitabine
gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Active Comparator: Chemotherapy

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of nausea/vomiting
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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.
At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain numeric rating scale (NRS)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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.
At the end of Cycle 1 (each cycle is 28 days)
Quality of life (QOL)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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)
At the end of Cycle 1 (each cycle is 28 days)
Sleep quality index
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)
At the end of Cycle 1 (each cycle is 28 days)
Overall survival (OS)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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.
At the end of Cycle 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Guopei Luo, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 24, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTCA199-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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