Cisplatin for Cancer of Pancreas

1
Effectiveness
1
Safety
Emory University/Winship Cancer Institute, Atlanta, GA
Cancer of Pancreas+20 More
Cisplatin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a combination of drugs may help treat patients with advanced solid tumors.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Breast Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Sarcoma
  • Lung Cancer
  • Breast Neoplasms
  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • Breast Cancer, Stage IIIB
  • Breast Cancer Stage IIIc
  • Stage III Pancreatic Cancer
  • Head and Neck Cancer
  • Solid Neoplasms
  • Stage IIIA Breast Cancer
  • Stage IVA Pancreatic Cancer
  • Stage IIIA Non Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Carcinoma Breast Stage IV
  • Colorectal Carcinoma (CRC)
  • Bladder Cancer, Cancer
  • Ovarian Cancer
  • Cancer of Unknown Primary
  • Lung Neoplasms
  • Stage IVB Pancreatic Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Cisplatin will improve 3 primary outcomes and 3 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of Up to 4 weeks.

Year 2
Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Recommended phase 2 dose (RP2D) as the highest doses of palbociclib and cisplatin or palbociclib and carboplatin
Up to 3 years
Overall response rate (complete response + partial response) assessed by Response Evaluation Criteria in Solid Tumors 1.1 criteria
Up to 4 weeks
Incidence of dose limiting toxicities defined as grade 3 or higher toxicity
Pharmacokinetic (PK) characteristics of carboplatin including maximum concentration (Cmax)
Pharmacokinetic (PK) characteristics of cisplatin including maximum concentration (Cmax)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Arm A (palbociclib, cisplatin)

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cisplatin 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 and are in the first stage of evaluation with people.

Arm A (palbociclib, cisplatin)Patients receive cisplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm B (palbociclib, carboplatin)Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Carboplatin
FDA approved
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
O. A.
Olatunji Alese, MD
Emory University

Closest Location

Emory University/Winship Cancer Institute - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically or cytologically confirmed solid organ malignancy
Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Leukocytes ≥ 3,000/mL
Absolute neutrophil count ≥ 1,500/mL
Platelets ≥ 100,000/mL
Hemoglobin ≥ 10 g/dL
Total bilirubin ≤ 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal [ULN] for patients with liver metastasis)

Patient Q&A Section

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

Can cancer of pancreas be cured?

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There has not been any cure of cancer of pancreas, probably due to the complicated nature of this disease. In our study, the patients who were cured of cancer of pancreas lost a significant life span. But it appears that people can be monitored to prevent death without any curative procedures.

Unverified Answer

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

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[The average age of diagnosis of pancreatic cancer in the U.S. has declined by 2.5 years in all persons diagnosed with pancreatic cancer over the 30-year period 1986-2011, but there has not been appreciable overall change in the age at diagnosis of pancreatic cancer in the past 3 decades.] In the last U.S. population-based studies, the incidence of pancreatic cancer has increased 2-fold over the 40 years from 1971–1991.

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What are the signs of cancer of pancreas?

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The signs of cancer of pancreas include lack of appetite, nausea, vomiting, stomach pain or bloating. On physical examination, these individuals may present with tenderness, weakness, altered stool habit or bloody stool. A mass could be palpated or feel larger on physical examination.\n

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What are common treatments for cancer of pancreas?

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Patients with pancreas cancer can be managed successfully with surgery and chemotherapy. Patients with liver metastases from pancreatic cancer can be managed effectively with multimodal treatment of chemotherapy, radiotherapy, and transarterial embolization.

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What is cancer of pancreas?

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The presence of cancer does not increase in all cases of acute abdomen, it is mostly observed in patients with chronic pancreatitis in whom pain increases due to increased secretory secretion of pancreatic enzymes. There is some evidence that shows that there is a possible increased risk of developing cancer in patients with pancreatitis and cancer. This is still controversial and further studies should be completed to confirm this data. Patients with a benign tumor of pancreas is usually observed until the last two rounds of chemotherapy. There is always a risk of pancreatic dysfunction due to surgery, which should be taken into account when the surgery is planned.

Unverified Answer

What causes cancer of pancreas?

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Many common cancers are associated with type 1-pancreatic cancer, such as ductal adenocarcinoma and ductal carcinoma in situ. However, many uncommon cancers are also associated with type 2-pancreatic cancers, such as intraductal papillary mucinous neoplasm and villoglandular adenocarcinoma. These data can be useful to formulate guidelines for management of early and late intraductal papillary mucinous neoplasm of the pancreas.

Unverified Answer

What is the latest research for cancer of pancreas?

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Even though there are great achievements in treatment for cancer of pancreas, cancer survival rate is still very low and need oncologists to be better and more focused. The research in pancreatic cancer is still in a middle stage. The quality of research and clinical trials need better improvements.

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Has cisplatin proven to be more effective than a placebo?

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Recent findings of our pilot study are in keeping with the most recent literature, suggesting that the use of cisplatin to treat the advanced or metastatic pancreatic disease may be more effective than a placebo. Recent findings will have to be confirmed to establish the role of cisplatin in the treatment of the neoplastic pancreas.

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How serious can cancer of pancreas be?

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Although pancreatic cancer is a rare tumor of the pancreas, advanced and late-stage stages of pancreatic cancer have been recorded in Western countries. Thus, pancreatic cancer is associated with a poor prognosis and high mortality rate, especially among the elderly. This review concludes by discussing the different risk factors involved in pancreatic cancer and an analysis of the current treatment of this disease.

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What is the average age someone gets cancer of pancreas?

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[The average age that someone gets [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) is 64 yrs old (according to SEER)(https://seer.cancer.gov/database/Site.aspx?SiteId=105712). And the average age the first pancreas cancer was diagnosed in is 58 yrs old (according to SEER)(https://seer.cancer.gov/database/Site.aspx?SiteId=92235)\n\nIn the United States, the lung and colorectal cancers are responsible for more deaths due to cancer than any other type of cancer in 2017.\nLung cancer incidence rates in the US are continuing to increase.

Unverified Answer

Is cisplatin safe for people?

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Cisplatin is an effective antitumor agent, however, cisplatin toxicity is also well described. In patients with advanced hepatic disease, it can cause serious hepatotoxicity. The patients who are exposed with high cisplatin are at the risk of kidney toxicity that can be potentially irreversible and requiring dialysis.

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Who should consider clinical trials for cancer of pancreas?

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Clinical trial is very effective even now because the cure is not obtained even after decades of attempts. The clinical trial is a method to detect and show effect of drug because it is less hazardous than other techniques such as open-label study with no control group. You can find the most recent clinical trials by using Power, which allows you to search trials tailored to your condition, location, and ideal treatment. You can check the table “Clinical Trial Registration” in https://www.clinicaltrials.gov/ before you decide to do clinical trials. Clinical trials are useful in order to get all the required data for future study.

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