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Alkylating agents

Arm I (nab-paclitaxel, gemcitabine, cisplatin) for Pancreatic Adenocarcinoma

Phase 2 & 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients whose front-line chemotherapy was simplified due to toxicity associated with FOLFIRINOX/NALIRIFOX

Patients with metastatic pancreatic adenocarcinoma, adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, or carcinoma not otherwise specified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to the date of death due to all causes, assessed up to 5 years

Awards & highlights

Study Summary

"This trial is comparing the effectiveness of a 3-drug chemotherapy combination versus a 2-drug chemotherapy combination for treating pancreatic cancer that has spread and contains specific genetic mutations."

Who is the study for?

This trial is for adults with metastatic pancreatic cancer that has spread and have a BRCA1, BRCA2, or PALB2 gene mutation. They should not have had cisplatin before but may have had gemcitabine and nab-paclitaxel if it was over a year ago. Participants must show disease progression after initial chemotherapy and be recovered from any significant side effects of previous treatments.Check my eligibility

What is being tested?

The PLATINUM Trial is testing whether adding cisplatin to the standard chemotherapy combo of nab-paclitaxel plus gemcitabine improves outcomes in patients with certain genetic mutations. It's a phase II/III study comparing these two chemo regimens using CT scans, MRI, and biospecimen collection to assess effectiveness.See study design

What are the potential side effects?

Chemotherapy drugs like nab-paclitaxel, gemcitabine, and cisplatin can cause side effects including nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, kidney issues, nerve damage resulting in numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My initial chemotherapy was changed due to side effects from FOLFIRINOX/NALIRIFOX.

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My cancer is a type of advanced pancreatic cancer.

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My cancer is linked to a harmful BRCA1/2 or PALB2 gene mutation.

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My cancer can be measured by tests.

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My cancer progressed after first-line FOLFIRINOX or NALIRIFOX treatment.

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My condition worsened while on maintenance PARP inhibitor treatment after FOLFIRINOX/NALIRIFOX.

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I have not been treated with cisplatin for my pancreatic cancer.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I am not pregnant or breastfeeding, and my pregnancy test was negative.

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My nerve damage in the hands and feet is mild or moderate.

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I am on treatment for hepatitis B and my viral load is undetectable.

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My hepatitis C is either cured or undetectable while on treatment.

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I am not taking medication that strongly affects liver enzyme activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of death due to all causes, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to the date of death due to all causes, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death due to all causes, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) (Phase III)

Overall response rate (ORR) (Phase II)

Secondary outcome measures

Incidence of adverse events

Progression-free survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (nab-paclitaxel, gemcitabine, cisplatin)Experimental Treatment6 Interventions

Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Group II: Arm II (nab-paclitaxel, gemcitabine)Active Control5 Interventions

Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Cisplatin

2013

Completed Phase 3

~1940

Gemcitabine

2017

Completed Phase 3

~2070

Nab paclitaxel

2014

Completed Phase 2

~70

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,066 Total Patients Enrolled

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,538 Total Patients Enrolled

Frequently Asked Questions

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

At how many different venues is this research endeavor being coordinated?

"The current investigation is operational in 126 diverse sites, including but not limited to Bardstown, Phoenix, and Mattoon. When considering enrollment, prioritize a site closest to your residence for convenience in commuting."

Answered by AI

What is the current number of participants under observation in this clinical investigation?

"A total of 100 eligible individuals are sought to join this research study. Participants have the opportunity to engage in this trial at diverse locations, including Flaget Memorial Hospital located in Bardstown, Kentucky, and the Cancer Center at Saint Joseph's in Phoenix, Arizona."

Answered by AI

Is the enrollment of participants currently ongoing for this research study?

"Indeed, data from clinicaltrials.gov affirms that this trial is actively enrolling participants. The study was initially listed on December 6th, 2023 and last revised on February 23rd, 2024. Recruitment aims to include a total of 100 individuals across 126 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer

2023. "The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115499.

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