Pazopanib for Carcinoid Tumor

Recruiting at 497 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

171 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Pazopanib Hydrochloride for treating carcinoid tumors?

Research shows that Pazopanib has been effective in treating advanced neuroendocrine tumors (NETs) and gastroenteropancreatic neuroendocrine tumors (GEP NETs), which are similar to carcinoid tumors. This suggests it might also help with carcinoid tumors. ^{1 2 3 4 5}

Is pazopanib generally safe for humans?

Pazopanib, used for treating renal cell carcinoma, has been associated with side effects like nausea, vomiting, diarrhea, high blood pressure, and liver issues. Most side effects are mild to moderate and can be managed, but it's important to monitor and address them early. ^{6 7 8 9 10}

How is the drug Pazopanib unique for treating carcinoid tumors?

Pazopanib is unique because it is an oral medication that targets multiple pathways involved in tumor growth, specifically inhibiting receptors like VEGFR, PDGFR, and c-Kit, which are not typically targeted by standard treatments for carcinoid tumors. This multi-target approach may offer a novel way to manage tumor growth compared to existing therapies. ^{5 11 12 13 14}

What is the purpose of this trial?

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Emily K Bergsland

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pazopanib in pretreated advanced neuroendocrine tumors: a phase II, open-label trial of the Spanish Task Force Group for Neuroendocrine Tumors (GETNE). [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Pazopanib pharmacokinetically guided dose optimization in three cancer patients with gastrointestinal resection. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phase II study of pazopanib monotherapy in metastatic gastroenteropancreatic neuroendocrine tumours. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Phase I, Dose-Escalation Trial of Pazopanib in Combination with Cisplatin in Patients with Advanced Solid Tumors: A UNICANCER Study. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Usefulness of Implementing Comprehensive Pharmaceutical Care for Metastatic Renal Cell Carcinoma Outpatients Treated with Pazopanib. [2021]

7. United States 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Occurrence of abscesses during treatment with pazopanib in metastatic renal cancer: a case report. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Pazopanib: an oral multitargeted tyrosine kinase inhibitor for use in renal cell carcinoma. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Pazopanib in the treatment of advanced renal cell carcinoma. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Pazopanib: in advanced renal cell carcinoma. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Pharmacokinetics and Pharmacodynamics of Pazopanib: Towards Optimized Dosing. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Incorporation of pazopanib in maintenance therapy of ovarian cancer. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

First-Line PAzopanib in NOn-clear-cell Renal cArcinoMA: The Italian Retrospective Multicenter PANORAMA Study. [2021]