RECRUITING

Gemcitabine, Cisplatin and Nab-Paclitaxel As Neoadjuvant Treatment for Patients with Resectable or Borderline Resectable Pancreatic Cancer

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Conditions

Borderline Resectable Pancreatic Ductal AdenocarcinomaResectable Pancreatic AdenocarcinomaStage I Pancreatic Cancer AJCC V8Stage II Pancreatic Cancer AJCC V8Stage III Pancreatic Cancer AJCC V8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy has been shown to improve overall survival compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Official Title

A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel As Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2024-08-06
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06423326

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma
  2. * Resectability will be defined as per National Comprehensive Cancer Network (NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed tomography or magnetic resonance imaging scans of the abdomen, and pelvis)
  3. * Decisions about resectability status will be made in consensus at multidisciplinary meetings/discussions
  4. * No interface of the tumor with celiac artery, common hepatic artery (CHA), or superior mesenteric arteries (SMA) (and, if present, variants)
  5. * Less than 180° interface between tumor and vessel wall of the portal or superior mesenteric veins (SMV) without vein contour irregularity
  6. * For tumors of the body and tail of the pancreas, interface with the splenic artery and splenic vein of any degree will be considered resectable disease
  7. * To include at least one of the following:
  8. * Tumor abutment \< 180° of the superior mesenteric artery or celiac axis
  9. * Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic artery bifurcation allowing for safe and complete resection and reconstruction
  10. * Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery)
  11. * Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of \> 180˚ of the diameter of the vessel
  12. * Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction
  13. * Solid tumor contact with inferior vena cava
  14. * Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA)
  15. * No distant extrapancreatic disease (M0)
  16. * Adults \> 18 years of age
  17. * Able to give informed consent
  18. * Able to adhere to study visit schedule and other protocol requirements
  19. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  20. * Absolute neutrophil count (ANC) ≥ 1,500 cells/ul
  21. * Platelet count ≥ 100,000 cells/ul
  22. * Hemoglobin ≥ 9 g/dL
  23. * Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  24. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  25. * Albumin ≥ 3 g/dl
  26. * Creatinine ≤ 1.5 x ULN
  27. * Male, or a non-pregnant and non-lactating female
  28. * Women of child-bearing potential - defined as a sexually mature woman who has not undergone hysterectomy - the surgical removal of the uterus or bilateral oophorectomy - the surgical removal of both ovaries or has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time during the preceding 24 consecutive months, must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete
  29. * Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy
  1. * Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
  2. * Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations
  3. * Pregnancy (positive pregnancy test) or lactation
  4. * Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \[RS\]; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
  5. * Previous (within the past 5 years) or concurrent presence of other untreated cancer, except nonmelanoma skin cancer and in situ carcinomas
  6. * History of allergy or hypersensitivity to any of the study drugs
  7. * Current abuse of alcohol or illicit drugs
  8. * Inability or unwillingness to sign the informed consent form

Contacts and Locations

Study Contact

Mihir M. Shah, MD
CONTACT
404-778-3307
mihir.m.shah@emory.edu

Principal Investigator

Mihir M Shah, MD
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Mihir M Shah, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

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 Registration Dates

Study Start Date2024-08-06
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-08-06
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Borderline Resectable Pancreatic Ductal Adenocarcinoma
  • Resectable Pancreatic Adenocarcinoma
  • Stage I Pancreatic Cancer AJCC V8
  • Stage II Pancreatic Cancer AJCC V8
  • Stage III Pancreatic Cancer AJCC V8