Losartan + Paclitaxel for Ovarian Cancer

Overseen By Oladapo Yeku, MD, Ph.D., FACP

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Antihypertensives, ACE/ARB inhibitors

Disqualifiers: Cardiac disease, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Estimated 24 months

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I have completed a specific number of previous treatments.

Subject must meet specified timelines for prior treatments

Participants must have measurable disease as per specified criteria

Exclusion Criteria

I have moderate numbness, pain, or tingling in my hands or feet.

I am not pregnant or breastfeeding.

I have heart problems or significant heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral losartan and weekly intravenous paclitaxel until disease progression, withdrawal, or unacceptable side effects

Estimated 24 months

Weekly visits for paclitaxel administration

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

30 days to indefinite, depending on condition

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?

Group I: Losartan + Paclitaxel Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07265739

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6369817/

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— ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30659155/

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.

4. biorxiv.org biorxiv.org/content/10.1101/2023.08.31.555783v1.full.pdf

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.aspx

Hypertension 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-cancer

Losartan and Paclitaxel in PROC | MedPath The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667005424000255

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.

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2802566

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.