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

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06115499

Provider View

This clinical trial is comparing two chemotherapy combinations to see which is more effective for treating metastatic pancreatic cancer in patients with specific genetic mutations (BRCA1, BRCA2, or PALB2).

Patient Parameters

Program Overview

This study is testing two different chemotherapy combinations to find out which works better for treating pancreatic cancer that has spread to other parts of the body and has specific genetic mutations (BRCA1, BRCA2, or PALB2). One group will receive a three-drug combination (nab-paclitaxel, gemcitabine, and cisplatin), while the other group will receive a two-drug combination (nab-paclitaxel and gemcitabine).

Description

The main goal of this study is to compare how well two different chemotherapy treatments work for patients with pancreatic cancer that has spread and has specific genetic mutations. The study will look at how many patients respond to the treatments and how long they live after treatment. It will also check how long the cancer stays under control and how the treatments affect patients' health.

Patients will be randomly assigned to one of two groups:

  • Group 1: Will receive nab-paclitaxel, gemcitabine, and cisplatin through an IV on days 1 and 15 of each 28-day cycle. They will also have regular MRI or CT scans and may give blood samples.

  • Group 2: Will receive nab-paclitaxel and gemcitabine through an IV on days 1 and 15 of each 28-day cycle. They will also have regular MRI or CT scans and may give blood samples.

After finishing the treatment, patients will have follow-up visits every three months for two years or until they pass away.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic pancreatic cancer, including certain subtypes.
  • Have a BRCA1, BRCA2, or PALB2 mutation confirmed by a certified lab.
  • Have cancer that can be measured by scans.
  • Have had cancer that progressed after first-line treatment with FOLFIRINOX or similar regimens.
  • Have not received cisplatin for pancreatic cancer before.
  • Be 18 years or older.
  • Have a performance status that allows for daily activities with some restrictions.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
  • Not have severe nerve damage.
  • Have no other cancers that could interfere with the study.
  • Have treated brain metastases with no progression for at least 8 weeks.
  • Have controlled HIV, hepatitis B, or hepatitis C infections if applicable.
  • Not be on certain medications that affect liver enzymes.

Exclusion Criteria

  • N/A

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