Study on Berzosertib and Irinotecan for Treating Advanced TP53 Mutant Stomach or Gastroesophageal Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03641313
This clinical trial is testing a combination of two drugs, berzosertib and irinotecan, to see if they can better treat stomach or gastroesophageal cancer that is advanced, spreading, or cannot be removed by surgery. The study aims to find out if this combination is more effective than irinotecan alone.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well the drugs berzosertib and irinotecan work together in treating patients with advanced stomach or gastroesophageal cancer that has a specific TP53 mutation. Berzosertib may help stop tumor growth by blocking certain enzymes, while irinotecan is a chemotherapy drug that kills cancer cells or stops them from spreading. Researchers hope that using both drugs together will be more effective than using irinotecan alone.
Description
The main goal of this study is to see if the combination of berzosertib and irinotecan can improve the response rate in patients with TP53 mutant stomach or gastroesophageal cancer compared to historical data of patients treated with irinotecan alone. Researchers will also look at how long the response lasts, the time it takes for the cancer to progress, and overall survival rates.
In addition, the study will explore how the treatment affects patients with other genetic mutations and those who responded well to previous platinum-based treatments.
Participants will receive irinotecan and berzosertib through an IV on specific days of a 28-day cycle, and the treatment will continue as long as it is effective and tolerable. Patients will also undergo biopsies and imaging tests to monitor the cancer's response to the treatment.
After completing the study treatment, participants will be followed up for 30 days and then every two months for up to a year to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have advanced stomach or gastroesophageal cancer that cannot be removed by surgery and has a TP53 mutation.
- Have measurable cancer that can be tracked using scans or exams.
- Have tried at least two previous treatments that did not work or were not tolerated.
- Be 18 years or older.
- Have a good performance status, meaning you can carry out daily activities with little or no assistance.
- Have adequate blood cell counts and organ function as determined by specific blood tests.
- Agree to use effective birth control during the study and for six months after the last dose of treatment.
- Be willing to sign an informed consent form and comply with study procedures.
Exclusion Criteria
- Have early-stage or treatable stomach cancer.
- Have received chemotherapy or radiation within the last four weeks.
- Have previously been treated with irinotecan.
- Have not fully recovered from side effects of previous cancer treatments.
- Have untreated or symptomatic brain metastases.
- Have a history of severe allergic reactions to similar drugs.
- Are taking medications that strongly interact with the study drugs.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Are pregnant or breastfeeding.
- Have HIV with a detectable viral load or are taking medications that interact with the study drugs.
- Have had another cancer within the last three years, unless it was a localized cancer that has not recurred.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | 33442 | Deerfield Beach | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Kendall | 33176 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Plantation | 33324 | Plantation | Florida |
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