Study on M6620 and Carboplatin With or Without Docetaxel for Treating Metastatic Castration-Resistant Prostate Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03517969
This clinical trial is testing how well the combination of M6620 and carboplatin, with or without docetaxel, works in treating prostate cancer that has spread and is resistant to hormone therapy. The study aims to see if adding M6620 can improve treatment outcomes compared to using carboplatin and docetaxel alone.
Patient Parameters
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Program Overview
This study is exploring a treatment for prostate cancer that has spread and is resistant to hormone therapy. It involves using a drug called M6620, which may help stop cancer cells from growing, along with chemotherapy drugs carboplatin and possibly docetaxel. The goal is to see if this combination can better control the cancer compared to using just carboplatin and docetaxel.
Description
The main goal of this study is to compare how well the combination of M6620 and carboplatin works against prostate cancer compared to the combination of docetaxel and carboplatin. Researchers will look at how much the cancer shrinks and how long it takes for the cancer to start growing again. They will also study the safety of these treatments and any side effects.
Participants will be randomly assigned to one of two groups:
- Group A: Receives docetaxel and carboplatin through an IV every 21 days, as long as the cancer does not worsen or side effects are manageable. If the cancer progresses, participants may switch to Group B.
- Group B: Receives carboplatin and M6620 through an IV every 21 days, as long as the cancer does not worsen or side effects are manageable.
After finishing the treatment, participants will have follow-up visits to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Have confirmed prostate cancer that is progressing despite hormone therapy.
- Cancer must have spread to other parts of the body and be measurable by scans or blood tests.
- Must have tried at least two previous treatments for prostate cancer, including hormone therapy and chemotherapy.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts and organ function, including:
- White blood cells of at least 3,000/mcL.
- Neutrophil count of at least 1,500/mcL.
- Hemoglobin level of at least 9 g/dL.
- Platelet count of at least 150,000/mcL.
- Normal liver and kidney function as indicated by specific blood tests.
- Agree to use effective contraception during the study and for six months after treatment.
- Be willing to sign a written informed consent document.
Exclusion Criteria
- Have received chemotherapy or radiotherapy within the last 4 weeks.
- Have not recovered from side effects of previous cancer treatments.
- Are currently participating in another clinical trial.
- Have known brain metastases or cancer spread to the brain.
- Have a history of severe allergic reactions to similar drugs used in the study.
- Are taking medications that could interfere with the study drugs.
- Have uncontrolled illnesses such as heart failure or infections.
- Are pregnant or breastfeeding.
- Have HIV with a detectable viral load or low CD4 count.
- Have previously been treated with platinum-based chemotherapy or ATR inhibitors for prostate cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
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