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

Must not be taking: CYP3A4 inhibitors

Disqualifiers: Hypertension, Heart failure, CNS metastases, others

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

Compensation: Varies

Number of Visits: 4

Duration: 28 days per cycle, repeated until disease progression or unacceptable toxicity

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

Group I: Arm I (pazopanib hydrochloride) Experimental Treatment 9 Interventions

Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

Group II: Arm II (placebo) Placebo Group 9 Interventions

Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12457709/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01841736

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7154093/

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 ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO-24-02644

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 ...

5. nature.com nature.com/articles/bjc2013470

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01841736

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 ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT01841736

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 ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/022465lbl.pdf

Votrient (pazopanib) - accessdata.fda.gov VOTRIENT (pazopanib) tablets. Initial U.S. Approval: 2009. WARNING: HEPATOTOXICITY. See full prescribing information for complete boxed warning.

9. mayoclinic.org mayoclinic.org/drugs-supplements/pazopanib-oral-route/description/drg-20073458

Pazopanib (oral route) - Side effects & dosage Pazopanib interferes with the growth of cancer cells, which are eventually destroyed by the body. This medicine is available only with your doctor's ...