Study on Weekly Chemo/Immunotherapy for Patients with Metastatic Head and Neck Cancer
Sponsor: Wake Forest University Health Sciences
ClinicalTrials ID:NCT04858269
This clinical trial is exploring the effects of a treatment combination of chemotherapy (carboplatin and paclitaxel) and immunotherapy (pembrolizumab) for patients with metastatic head and neck squamous cell carcinoma who cannot take the drug 5-fluorouracil.
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Program Overview
The aim of this study is to find out how well a combination of chemotherapy drugs (carboplatin and paclitaxel) and an immunotherapy drug (pembrolizumab) works in treating patients with metastatic head and neck squamous cell carcinoma. This treatment is for patients who cannot use the drug 5-fluorouracil. Researchers want to see if this combination can improve the response rate, overall survival, and progression-free survival compared to using pembrolizumab alone. They will also monitor any side effects that might cause patients to stop the treatment.
Description
The main goal of this study is to see if using pembrolizumab with weekly doses of carboplatin and paclitaxel for six cycles can improve the response rate in patients with metastatic head and neck squamous cell carcinoma, compared to historical data for pembrolizumab alone.
Secondary goals include:
- Checking if this treatment combination can increase the average overall survival time compared to pembrolizumab alone.
- Seeing if the treatment can extend the time patients live without the cancer getting worse, compared to pembrolizumab alone.
- Evaluating the side effects of this treatment combination, especially if they lead to stopping the treatment, compared to historical data for a different treatment combination (platinum/5FU/pembrolizumab).
Eligibility Criteria
Inclusion Criteria
- Have recurrent or metastatic squamous cell carcinoma in areas like the mouth, throat, or voice box that cannot be cured with local treatments like surgery or radiation.
- Cancer must be confirmed by a pathology report.
- Cannot take the drug 5-fluorouracil for reasons like mouth sores or patient choice.
- Be 18 years or older.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of more than 3 months.
- Have normal organ and bone marrow function, including specific blood cell counts and bilirubin levels.
- Be able to understand and sign a consent form, either directly or through a representative.
Exclusion Criteria
- Have not received any cancer treatment for recurrent or metastatic cancer, except treatments given with the intent to cure before the disease became incurable.
- Have untreated, symptomatic cancer spread to the brain or spinal cord.
- Have an active autoimmune disease needing systemic treatment.
- Have a history of severe lung inflammation needing high-dose steroids.
- Have had a severe allergic reaction to carboplatin or paclitaxel.
- Have uncontrolled illnesses like infections, heart failure, or psychiatric conditions that would interfere with the study.
- Pregnant women cannot participate due to potential risks to the baby, and breastfeeding should be stopped during the study.
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