Treatment for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
1
Safety
Ochsner Clinic Foundation, New Orleans, LA
Cancer of Pancreas+1 More
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Malignant Neoplasm of Pancreas

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes, 12 secondary outcomes, and 2 other outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of At various post-infusion time points assessed up to 22 weeks.

28 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
44 days
To establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer.
Week 24
Objective Response Rate
Week 24
Plasma/serum concentration of XB2001
Week 22
Results of a symptom questionnaire will be summarized by treatment arm at various post-infusion time points and compared over time
Week 2
Change in (CD14+CD16+IL-1⍺+) triple positive tumor associated monocytes in peripheral blood
Week 4
Duration of hospitalizations
Week 8
Quality of Life assessed through the cancer-specific European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-C30
Week 8
Percentage of Patients with Clinical Benefit Response
Week 22
Cardiotoxicity measured by the number of required ECGs and cardiotoxicity related events summarized by treatment arm and compared over time
Week 24
Incidence of Grade 3-4 Diarrhea
Week 24
Number of Serious Adverse Events (SAEs)
Week 24
Time to Treatment Failure
Week 24
Overall Survival (OS)
Week 24
Progression Free Survival
Week 24
Number of Treatment Cycles

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Arm 2
Placebo group

This trial requires 69 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm 2
Biological
Placebo + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment • Arm 2 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: Placebo as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).
Arm 1
Biological
XB2001 + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment • Arm 1 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: XB2001 MTD as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-Fluorouracil 2400mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to weeks 4, 8, 12, 16, 20 and 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to weeks 4, 8, 12, 16, 20 and 24 for reporting.

Closest Location

Ochsner Clinic Foundation - New Orleans, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer of Pancreas or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1
Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy
Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70
Adequate hepatic, renal and bone marrow function

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 common treatments for cancer of pancreas?

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Findings from a recent study confirmed the value of radical surgery in pancreatic cancer; however, in a large proportion of patients adjuvant therapy has to be considered. Chemotherapy remained a therapeutic option. New developments in imaging and radiotherapy warrant further clarification.

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Can cancer of pancreas be cured?

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We could not find any benefit of surgical resection and adjuvant chemotherapy in terms of overall or local long-term survival rate. The authors conclude that surgical resection alone is not advisable to be used for the treatment of cancer of the pancreas.

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What causes cancer of pancreas?

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The main risk factors of pancreas cancer are smoking, alcohol consumption, obesity, and diabetes. Most of pancreas cancers develop from chronic pancreatic diseases or from benign tumors in the pancreas. Alcohol consumption has an adverse impact on the natural history and prognosis of the disease.

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What is cancer of pancreas?

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Pancreatic cancer is the tenth most common cancer worldwide, with an annual incidence of over 25,000 cases, and is a disease where survival depends on an early diagnosis. A high occurrence of pancreatic neuroendocrine neoplasms and a poorer prognosis justifies a more detailed epidemiological screening for such neoplasms.

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How many people get cancer of pancreas a year in the United States?

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At a population level in the US of people diagnosed with cancer of pancreas there are more women than men. The proportion of patients diagnosed with cancer in pancreas has decreased between the years of 1990-2004, with the exception of patients diagnosed in 2009-2014, but the trends are similar among other conditions. The percentage of pancreas cancer in females has remained around 90% for all diagnoses and for all age groups, with the exception of patients aged 70-79. Pancreas cancer and C-cell carcinoma remain the two most common types of cancer reported.

Unverified Answer

What are the signs of cancer of pancreas?

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Signs of pancreatic cancer include a sudden sharp, intense, high-pitched pain or burning in the upper part of the back, flank, chest and/or abdomen. The pain appears to be steady or in quick succession. The pain is often dull or achy although sometimes sudden, severe, and sometimes stabbing or stabbing and throbbing. These signs are referred from the pancreas and often lead to the discovery of an obstructing obstruction. The obstruction causes increased pressure (bodily) or air (vascular) within the pancreatic cavity. Signs of obstructive jaundice or bleeding may be present. There may also be changes in appetite.

Unverified Answer

Who should consider clinical trials for cancer of pancreas?

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There are many different clinical trials available for cancer of pancreas. It is difficult to select which to enter. We consider the following points before entering a clinical trial (1) type of treatment being studied, (2) type of chemotherapy administered, (3) whether it will be adjuvant or neoadjuvant, (4) the expected benefit to the patients, (5) cost, and (6) the likelihood of survival benefit.

Unverified Answer

What is the survival rate for cancer of pancreas?

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Pancreatic cancer is a rare disease and has a poor overall survival rate. The mean survival rate was 14.2 months since its diagnosis in the past 4 years. In spite of such low survival rate, some patients with pancreatic cancer benefited from surgical treatment. Although curative resection is the only possible treatment for pancreatic cancer, some patients might also survive if they can get a radical resection with complete disease removal. To improve the survival rate of patients with curative resection, adjuvant treatment should be investigated.

Unverified Answer

Have there been any new discoveries for treating cancer of pancreas?

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Only 5% of the reported trials on pancreatic cancer in the last 5 years have been in the first line treatment. Combining CT with chemotherapy is used more frequently as compared with CT alone. It seems that our field of knowledge of pancreatic cancer and treatment is moving very fast. At the moment, it is not possible to predict the outcome of the treatment with high accuracy.

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What is the primary cause of cancer of pancreas?

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The main cause of pancreatic cancer is chronic pancreatitis (66%) followed by pancreatic ductal adenocarcinoma (23%). Both conditions need to be well managed to treat them.

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What are the latest developments in treatment for therapeutic use?

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The most recent studies have shown that [cytotoxic drugs] can be extremely effective in treating pancreatic cancer and they are the best tolerated by patients. Additionally, they are highly effective and can provide a survival time benefit to patients that would otherwise have been denied otherwise based on the disease itself in this era of chemotherapy. However, [antibiotic drugs] are still considered first line of treatment and are being used for treatment of this disease and can work to inhibit bacterial infection.

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What is the latest research for cancer of pancreas?

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The treatment of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) depends on age and the type of tumor that grows; it varies enormously depending on the stage of diagnosis; and the results of clinical trials are often controversial. The use of pancreatic cancer therapy is only suggested or discouraged by the National Comprehensive Cancer Network. Because there are few randomized trials with long-term follow-ups, there are many questions that need to be more fully explored. New approaches, new technologies, and new combinations of medicines have the highest potential to improve the management of patients with pancreatic cancer.

Unverified Answer
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