Pazopanib for Carcinoid Tumor

Not currently recruiting at 511 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Must be taking: Somatostatin analogs
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pazopanib hydrochloride can prevent carcinoid tumors from growing, spreading, or worsening. The researchers compare pazopanib hydrochloride, which blocks enzymes that promote tumor cell growth, with a placebo. They seek participants with carcinoid tumors that are inoperable or have spread, and whose disease has worsened despite previous treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on strong CYP3A4 inhibitors, you must stop them 14 days before starting the study treatment. You can continue using somatostatin analogs if you are on a stable dose.

Is there any evidence suggesting that pazopanib hydrochloride is likely to be safe for humans?

Research has shown that pazopanib hydrochloride, the treatment tested in this trial, has undergone previous study. One study found that pazopanib controlled disease in 90.3% of patients with advanced neuroendocrine tumors, suggesting it might help control tumor growth.

Pazopanib is also FDA-approved for treating other cancers, but it can cause liver damage. Some patients have experienced side effects like high blood pressure, diarrhea, and changes in hair color, which are usually manageable with medical help.

This trial is in phase II, meaning researchers are still testing pazopanib for safety and effectiveness in this specific type of tumor. So far, data shows it is generally well-tolerated, but monitoring for side effects is important. Discuss the risks and benefits with the trial team before deciding to participate.12345

Why do researchers think this study treatment might be promising?

Pazopanib hydrochloride is unique because it targets and inhibits specific proteins known as tyrosine kinases, which play a role in tumor growth and blood vessel formation. Unlike standard treatments for carcinoid tumors, which often involve surgery, chemotherapy, or hormone therapy, pazopanib offers a targeted approach that may slow or stop the progression of the disease by cutting off the blood supply to the tumor. Researchers are excited about its potential to provide a more focused treatment with possibly fewer side effects compared to traditional chemotherapy, giving patients a new option in managing their condition.

What evidence suggests that pazopanib hydrochloride might be an effective treatment for carcinoid tumors?

Research has shown that pazopanib hydrochloride, which participants in this trial may receive, can help treat carcinoid tumors. In one study, patients taking pazopanib lived without tumor growth for an average of 11.8 months, compared to 7.6 months for those on a placebo. This indicates that pazopanib slowed tumor growth for a longer period. Another study found that pazopanib controlled the disease in 90.3% of patients with advanced neuroendocrine tumors, which are similar to carcinoid tumors. Additionally, in a different group of patients, 18.9% experienced some tumor shrinkage. These findings suggest that pazopanib can effectively manage tumor growth in patients with carcinoid tumors.26789

Who Is on the Research Team?

EK

Emily K Bergsland

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

Adults with low or intermediate-grade neuroendocrine carcinoid tumors that can't be surgically removed or have spread, and show signs of progression. Participants must not have high-grade variants, significant recent cardiovascular issues, uncontrolled blood pressure, bleeding risks, immune compromise conditions, or certain gastrointestinal problems. Pregnant women and those on strong CYP3A4 inhibitors are excluded.

Inclusion Criteria

No concurrent condition resulting in immune compromise
Your heart's pumping ability is strong (ejection fraction > 50%).
My scans show my cancer has worsened in the last year.
See 34 more

Exclusion Criteria

I have symptoms of poor blood flow in my limbs.
Pregnancy or nursing
My blood clotting time is slightly higher due to my anticoagulant medication.
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive pazopanib hydrochloride or placebo orally once daily in 28-day cycles

28 days per cycle, repeated until disease progression or unacceptable toxicity
Regular visits for CT, MRI, and chest x-ray

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3-6 months for up to 5 years
Follow-up visits every 3-6 months

Crossover

Participants on placebo may cross over to receive pazopanib upon disease progression

Until disease progression or unacceptable toxicity

What Are the Treatments Tested in This Trial?

Interventions

  • Pazopanib Hydrochloride
Trial Overview The trial is testing the effectiveness of Pazopanib Hydrochloride in slowing down or stopping tumor growth compared to a placebo. It's randomized and includes various assessments like echocardiography and MRI to monitor heart function and tumor changes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (pazopanib hydrochloride)Experimental Treatment9 Interventions
Group II: Arm II (placebo)Placebo Group9 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A comprehensive pharmaceutical intervention for 37 outpatients receiving pazopanib for renal cell carcinoma significantly reduced the incidence of grade 2 or more nausea (3% vs. 38%) and anorexia (8% vs. 46%) compared to a control group of 13 patients, indicating improved management of adverse events.
The intervention also led to increased adherence to treatment and a longer median time to treatment failure (10.2 months vs. 1.7 months), suggesting that early management of side effects can enhance overall treatment outcomes.
Usefulness of Implementing Comprehensive Pharmaceutical Care for Metastatic Renal Cell Carcinoma Outpatients Treated with Pazopanib.Todo, M., Shirotake, S., Nishimoto, K., et al.[2021]
Pazopanib, an antineoplastic agent approved by the European Commission for advanced renal cell carcinoma, significantly increases progression-free survival, with a median of 9.2 months compared to 4.2 months for placebo in the pivotal trial VEG105192.
Common side effects of pazopanib include diarrhea, hypertension, and fatigue, highlighting the need for monitoring during treatment.
The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.Nieto, M., Borregaard, J., Ersbøll, J., et al.[2021]

Citations

Randomized phase II trial of pazopanib versus placebo in ...About half (49%) of the patients had functional tumors. The median follow-up was 61 months (95% CI: 60 – 63). Median PFS was 11.8 vs. 7.6 months ...
NCT01841736 | Pazopanib Hydrochloride in Treating ...This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting ...
Phase-II Trials of Pazopanib in Metastatic Neuroendocrine ...Conclusions: Pazopanib monotherapy achieved a DCR of 90.3% in patients with locally advanced and/or metastatic neuroendocrine neoplasia, with an ...
Randomized Phase II Trial of Pazopanib Versus Placebo in ...About half (49%) of the patients had functional tumors. The median follow-up was 61 months (95% CI, 60 to 63). Median PFS was 11.8 versus 7.6 ...
Phase II study of pazopanib monotherapy in metastatic ...By an intent-to-treat analysis including all patients, an overall response rate of 18.9% was demonstrated (95% CI, 8.0– 35.2%), with zero CR and ...
NCT01841736 | Pazopanib Hydrochloride in Treating ...This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting ...
Pazopanib Hydrochloride in Treating Patients With ...This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or ...
Votrient (pazopanib) - accessdata.fda.govVOTRIENT (pazopanib) tablets. Initial U.S. Approval: 2009. WARNING: HEPATOTOXICITY. See full prescribing information for complete boxed warning.
Pazopanib (oral route) - Side effects & dosagePazopanib interferes with the growth of cancer cells, which are eventually destroyed by the body. This medicine is available only with your doctor's ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security