Gemcitabine for Pancreatic Diseases

Phase-Based Estimates
1
Effectiveness
1
Safety
Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
Pancreatic Diseases+12 More
Gemcitabine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Pancreatic Diseases

Study Summary

This study is evaluating whether a combination of chemotherapy drugs may help treat pancreatic cancer.

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Eligible Conditions

  • Pancreatic Diseases
  • Adenocarcinoma
  • Glandular Neoplasms
  • Gastrointestinal Neoplasms
  • Cholera Infantum
  • Cancer of Pancreas
  • Cancer
  • Digestive System Neoplasms
  • Endocrine Gland Neoplasms
  • Hepatobiliary Disorders
  • Endocrine System Diseases
  • Neoplasms, Glandular and Epithelial
  • Gastrointestinal Diseases
  • Pancreatic Neoplasms
  • Neoplasm, Glandular
  • Neoplasms
  • Neoplasms, Pancreatic
  • Digestive System Diseases

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Gemcitabine will improve 2 primary outcomes and 4 secondary outcomes in patients with Pancreatic Diseases. Measurement will happen over the course of 4 years.

4 years
Part 1: Percentage of participants experiencing toxicities
Part 2: Disease Control Rate (DCR)
Part 2: Overall survival (OS)
Part 2: Percentage of participants experiencing toxicities with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan, a combinatorial therapy).
Part 2: Progression Free Survival (PFS)
Part 2: Response Rate (RR)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Cohort 2

This trial requires 86 total participants across 2 different treatment groups

This trial involves 2 different treatments. Gemcitabine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 2(21 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan
Cohort 1(28 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Capecitabine
FDA approved
Irinotecan
FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

Sidney Kimmel Comprehensive Cancer Center - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ability to understand and willingness to sign a written informed consent document.
Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
Patients with the presence of at least one measurable lesion.
Male or non-pregnant and non-lactating female of age >18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Must use acceptable form of birth control while on study.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the latest developments in capecitabine for therapeutic use?

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Because of recent trials that have shown that patients with pancreatic cancer can benefit from capecitabine treatment of advanced pancreatic cancer, it is expected that this drug will receive additional indication(s) for this therapeutic use over the next 10 years.

Unverified Answer

What is pancreatic diseases?

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The overall patient in-hospital complication rate is low; this is not surprising because the population, as well as outpatient settings, represents the care of the non-endoscopic treatment of digestive illnesses. The occurrence of post-endoscopic complications is of minor clinical relevance and does not necessitate inpatient hospitalisation. endoscopic treatment of most pancreatic diseases should be offered as an outpatient procedure or day care, except for diagnostic endoscopic procedures of the pancreas, for pancreatobiliary and gastrointestinal surgery, or for endoscopic interventional pancreatology.

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What causes pancreatic diseases?

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Data from a recent study provides evidence that certain genetic factors predispose an individual to developing pancreatic disease, but this does not apply to all patients with pancreatic disease in their families.

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What are common treatments for pancreatic diseases?

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Some patients with chronic pancreatitis need pancreatic resection to treat severe pancreatic dysfunction; other patients with benign pancreatic disorders may be successfully managed with medications. Most, if not all patients with chronic pancreatitis have pancreatic-related pain, which responds well to NSAIDs, although a minority still have significant pain after 5 years. Most patients with chronic pancreatitis and pancreatitis-related diabetes undergo pancreatic surgery during initial evaluation to treat severe pancreatic dysfunction, the complications of which may be treated with medications. There is a specific focus on pancreatitis-related chronic pancreatitis-related pain following initial decompression, as this subset has poor response to standard NSAIDs and is at high risk for the development of severe pancreatitis.

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Can pancreatic diseases be cured?

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It is well established that pancreatic ductal adenocarcinoma is a curable disease with surgery; however, it is important that the tumor be resected as early as possible. Pancreatic adenocarcinoma in the tail is especially curable because metastases are uncommon, but metastases of the head of pancreas can grow and spread rapidly and are more aggressive. PDA of the ampulla is curable with surgical resection; however, it is the most difficult pancreatic tumor to resect because it can extend into the retroperitoneum. Pancreatic adenocarcinoma of the head is sometimes curable with medical oncologic therapy.

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What are the signs of pancreatic diseases?

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Diabetes mellitus and pancreatitis often present separately in the clinical setting, but their association with pancreatic cancer may be underrecognized. To obtain sufficient diagnostic accuracy, clinicians should work in close collaboration with specialists and consider screening tests such as serum biomarkers and computed tomography (CT) of the pancreas.

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How many people get pancreatic diseases a year in the United States?

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The combined number of PD and chronic pancreatitis in the United States is around one million patients per year, and is forecast to reach five million by 2020. These patients are at high risk of pancreatic failure, and often require liver transplantation. Clinicians should consider all symptomatic and/or asymptomatic patients diagnosed with PD and/or chronic pancreatitis for liver evaluation.

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What is the average age someone gets pancreatic diseases?

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A person with pancreatic diseases will typically be between 55 and 92 years of age. Because of the high age of onset, this group of individuals is at an increased risk to develop benign pancreatic diseases.

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Is capecitabine safe for people?

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Results from a recent clinical trial is the largest cohort of people in a randomized controlled trial of capecitabine for advanced cancers, and demonstrates an acceptable safety profile for this chemotherapeutic agent for the treatment of people with advanced solid tumors. It also highlights the issues of safety when comparing chemotherapy regimens.

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Is capecitabine typically used in combination with any other treatments?

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The use of capecitabine in combination with other treatments is increasing, but only when compared to the capecitabine monotherapy schedule. This increase in clinical evidence supports the need for more large multicenter studies that adequately compare capecitabine in combination with other treatments with capecitabine monotherapy.

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How serious can pancreatic diseases be?

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Pancreatic diseases are related to mortality, complications, and quality of life even in mild cases that may be asymptomatic. Patients must consider the potential of complications with pancreatic diseases during and after the course of treatment. Further research is needed to ascertain what care is most effective, but patients also need information about the possible complications, in order to minimize the risk, decrease the anxiety of the patients, and facilitate their satisfaction with the care received.

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Does pancreatic diseases run in families?

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The current study suggests that the occurrence of the pancreatic diseases in the family is influenced by different genetic and environmental factors that alter the expression and/or function of relevant genes (HLA).

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