Losartan + Paclitaxel for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for ovarian cancer that resists traditional platinum-based chemotherapy. Researchers aim to determine if combining losartan, a drug commonly used for high blood pressure, with paclitaxel, a standard chemotherapy drug, can better manage this cancer. Participants should have ovarian cancer that returned less than six months after completing platinum treatment and should not have conditions like uncontrolled high blood pressure or serious heart issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in ovarian cancer treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking medications for high blood pressure, you may need to stop them, as the trial excludes those on certain blood pressure medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is examining how the combination of losartan and paclitaxel affects ovarian cancer. Losartan, typically used for high blood pressure, may enhance the effectiveness of paclitaxel, a chemotherapy drug.
Previous patients have generally tolerated this combination well. Studies on paclitaxel have noted common side effects like hair loss and tiredness, which are usually manageable. Limited information exists on side effects specific to using losartan with paclitaxel. However, this Phase 2 study indicates that earlier tests showed it was safe enough to continue researching.
Overall, while side effects can occur, early results suggest this treatment might be a promising option for those with ovarian cancer that doesn't respond to standard treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Losartan and Paclitaxel for ovarian cancer because this approach uniquely combines a blood pressure medication with a traditional chemotherapy agent. Losartan is thought to enhance the delivery and effectiveness of Paclitaxel by improving blood flow to the tumor. This combination could potentially increase the chemotherapy's ability to reach and destroy cancer cells, offering a new angle compared to the current standard treatments like Carboplatin and Paclitaxel alone. By targeting the tumor environment and not just the cancer cells directly, there's hope for improved outcomes for patients.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research shows that combining losartan with paclitaxel, a chemotherapy drug for ovarian cancer, may enhance treatment effectiveness. Studies have found that losartan improves paclitaxel's ability to reach cancer cells, potentially causing tumors to shrink or stop growing. Additionally, losartan might help the immune system combat cancer cells. These findings strongly support using losartan and paclitaxel together, which participants in this trial will receive, for treating ovarian cancer unresponsive to standard treatments.12678
Who Is on the Research Team?
Oladapo Yeku, MD, Ph.D., FACP
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal carcinoma that's resistant to platinum-based treatments. Participants must have had certain prior therapies and be in a condition where they can follow the study procedures. Pregnant women, those with significant heart disease, uncontrolled infections, or severe allergies to paclitaxel are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily oral losartan and weekly intravenous paclitaxel until disease progression, withdrawal, or unacceptable side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment. Those with disease progression are followed for 30 days, while those with unacceptable side effects have visits and imaging every 9 weeks until a different treatment is started
What Are the Treatments Tested in This Trial?
Interventions
- Losartan
- Paclitaxel
Trial Overview
The Phase II study tests how effective the combination of losartan and paclitaxel is against platinum-resistant ovarian cancer. The goal is to see if this drug duo can help manage the disease better than current standard treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Once daily oral losartan combined with paclitaxel administered intravenously once weekly. Each cycle is 21 days and participants may receive study treatment until disease progression or withdrawal. Losartan and paclitaxel are administered at a pre-determined dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
American Cancer Society, Inc.
Collaborator
Citations
Study Details | NCT07265739 | Losartan and Paclitaxel in ...
The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival.
Losartan treatment enhances chemotherapy efficacy and ...
We report here four translatable findings: (i) losartan treatment enhances the efficacy of paclitaxel—a drug used for ovarian cancer treatment— ...
Losartan treatment enhances chemotherapy efficacy and ...
Our findings provide the rationale and supporting data for a clinical trial on combined losartan and chemotherapy in ovarian cancer patients.
Losartan rewires ovarian cancer tumor-immune ...
As a result of the combined tumor and stromal effects, losartan treatment enhances the efficacy of chemo-immunotherapy in OvCa models. The ...
5.
news-medical.net
news-medical.net/news/20190116/Hypertension-drug-may-improve-effectiveness-of-ovarian-cancer-treatment.aspxHypertension drug may improve effectiveness of ovarian ...
Colony-stimulating factor-1 receptor inhibition combined with paclitaxel exerts effective antitumor effects in the treatment of ovarian cancer.
6.
trial.medpath.com
trial.medpath.com/clinical-trial/4805e87e9816d327/nct07265739-losartan-paclitaxel-platinum-resistant-ovarian-cancerLosartan and Paclitaxel in PROC | MedPath
The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival.
Efficacy and safety of paclitaxel liposome versus ...
The findings affirm the non-inferiority of paclitaxel liposome compared to the combination of paclitaxel and carboplatin regarding therapeutic efficacy.
Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs ...
The overall response rate was 52% (13 of 25) and median PFS was 5.8 months (95% CI, 3.3-18.5) in the HGSC cohort.
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