Study on Tadalafil and Chemotherapy for Treatable Stomach and Gastroesophageal Cancer
Sponsor: University of Arizona
ClinicalTrials ID:NCT05709574
This clinical trial is exploring whether Tadalafil, a medication, can be safely combined with chemotherapy to help treat stomach and gastroesophageal cancer that can be surgically removed. The study aims to see if this combination can reduce certain cells that help cancer grow.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if Tadalafil, when used alone or with chemotherapy drugs (5-Fluorouracil, Oxaliplatin, and Docetaxel), can reduce specific cells that support cancer growth in patients with stomach or gastroesophageal cancer that can be surgically removed. Participants will take Tadalafil for 14 days, followed by a combination of Tadalafil and chemotherapy for about 8 weeks before surgery. The study will collect samples of tumor tissue, blood, urine, and saliva to analyze the effects of the treatment.
Description
This study is investigating a new approach to treating stomach and gastroesophageal cancer that can be surgically removed. Despite current treatments, survival rates for these cancers remain low, and there is a need for new therapies. The study focuses on myeloid-derived suppressor cells (MDSCs), which help cancer grow by suppressing the immune system and aiding in tumor spread. Tadalafil, a drug known to inhibit these cells, is being tested in combination with chemotherapy to see if it can improve treatment outcomes.
Participants will receive Tadalafil for 14 days, followed by a combination of Tadalafil and chemotherapy (FLOT) for about 8 weeks. The study will collect tumor tissue, blood, urine, and saliva samples at different stages to understand how the treatment affects the tumor environment. The goal is to see if this combination can reduce MDSCs and improve the effectiveness of chemotherapy.
The study will enroll 10 patients and aims to determine if this treatment approach is safe and effective in reducing the immune-suppressive environment around the tumor.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage I-III stomach or gastroesophageal cancer that can be surgically removed.
- Cancer must be measurable by scans done within 28 days before starting treatment.
- Age 18 years or older.
- Good organ and bone marrow function based on specific blood test results.
- Able to perform daily activities with minimal restrictions (ECOG performance status 0 or 1).
- Agree to use effective birth control during the study and for 6 months after treatment.
- Women must not be pregnant and must have a negative pregnancy test before starting treatment.
- Able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Previous treatment for stomach cancer.
- Use of Tadalafil or similar drugs within 28 days before the study.
- Cancer that has spread to other parts of the body.
- Uncontrolled or serious health conditions, such as heart problems or high blood pressure.
- Active or history of autoimmune diseases, except for certain controlled conditions.
- Active infections requiring treatment, except for urinary tract infections or treated hepatitis C.
- Recent COVID-19 infection unless recovered for 30 days before starting treatment.
- Known HIV or tuberculosis infection.
- Use of certain medications that interact with Tadalafil.
- Serious non-healing wounds or liver problems.
- Major surgery within 2 weeks before starting treatment.
- Use of immunosuppressive medications within 2 weeks before starting treatment, with some exceptions.
- Pregnant or breastfeeding women, or those planning to become pregnant during the study.
- Inability to swallow tablets.
- Allergy to study medications.
- History of specific eye conditions.
- Other active cancers requiring treatment, except for certain skin or localized cancers.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.