Ramucirumab + Somatostatin Analog for Carcinoid Tumor

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Antiplatelets, NSAIDs

Disqualifiers: Pancreatic tumors, Hypertension, Heart failure, 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: 13

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Ramucirumab, combined with a medication already used for certain tumors, to determine its effectiveness in treating advanced carcinoid tumors that are worsening. Carcinoid tumors are a type of slow-growing cancer that can develop in various parts of the body. Participants must have a confirmed diagnosis of a carcinoid tumor that is locally advanced, inoperable, or has metastasized. The trial specifically seeks individuals whose tumors have worsened in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients on certain medications like chronic antiplatelet therapy (except low-dose aspirin). It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining ramucirumab with somatostatin analogs may help treat advanced carcinoid tumors. In earlier studies, most patients tolerated this treatment well, experiencing mild to moderate side effects. Some individuals experienced higher blood pressure, fatigue, or diarrhea, but regular care managed these issues.

These findings suggest that the treatment is safe enough for continued study in clinical trials. Side effects can vary, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Ramucirumab and a Somatostatin Analog for treating carcinoid tumors because it offers a novel approach by targeting blood vessel growth in tumors. Unlike typical treatments that primarily focus on controlling hormone symptoms, Ramucirumab works as a VEGF receptor 2 antagonist, effectively disrupting the tumor's blood supply and potentially inhibiting its growth. This dual approach not only aims to manage symptoms but also directly combats the tumor's progression, offering hope for more comprehensive management of the condition.

What evidence suggests that Ramucirumab + Somatostatin Analog might be an effective treatment for carcinoid tumors?

In this trial, participants will receive Ramucirumab combined with a Somatostatin Analog to treat advanced carcinoid tumors. Studies have shown that this combination might benefit individuals with these tumors. In one study, some patients experienced a partial response, with their tumors shrinking. Specifically, about 10% of patients showed a significant decrease in Chromogranin A, a tumor marker indicating tumor activity. The treatment aims to prevent tumor progression, thereby improving progression-free survival. While these results are promising, they represent just one step in understanding the treatment's effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer A Chan, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with advanced, progressive carcinoid tumors (excluding pancreatic neuroendocrine tumors) who have shown disease progression in the last year. Participants must have measurable disease, stable organ and marrow function, no major surgery or chemotherapy within 4 weeks prior to enrollment, and not be on certain medications like chronic antiplatelet therapy. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.

My cancer has worsened in the last year, shown by scans.

I can carry out all my usual activities without help.

Exclusion Criteria

Patients who are receiving any other investigational agents.

I have painful gallstones.

I have not had severe gastrointestinal bleeding in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ramucirumab in combination with Somatostatin Analog every 14 days in a 28-day cycle

28 days per cycle

1 visit every 14 days

Follow-up

Participants are monitored for progression-free survival and overall survival

23.5 months

Survival collected every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ramucirumab
• Somatostatin Analog

Trial Overview The trial is testing Ramucirumab combined with Somatostatin Analog therapy for treating advanced carcinoid tumors. It aims to evaluate the effectiveness of this drug combination in controlling tumor growth.

How Is the Trial Designed?

Group I: Ramucirumab In Combination With Somatostatin Analog Experimental Treatment 2 Interventions

Patients will receive treatment with ramucirumab starting at a dose of 8 mg/kg intravenously every 14 days of a 28-day treatment cycle. Patients already receiving a somatostatin analog continued somatostatin analog therapy at their current dose. Patients not already receiving a somatostatin analog initiated treatment at an approved dose, according to institutional guidelines. Toxicity and adverse events will be examined in the first 10 patients who complete one cycle of therapy before expanding enrollment.

Ramucirumab is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer
• Hepatocellular carcinoma

Approved in European Union as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer

Approved in Japan as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39834129/

A phase II study of ramucirumab and somatostatin analog ... Patients were treated with ramucirumab 8 mg/kg intravenously on days 1 and 15 of each 28-day cycle. The primary endpoint was progression-free ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753395/

A phase II study of ramucirumab and somatostatin analog ... Best response by RECIST 1.1: partial response 5% (95% CI, 0.6%-15.8%). Chromogranin A levels dropped by at least 50% in 10% of the 37 patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02795858

A Phase II Study of Ramucirumab With Somatostatin ... The purpose of this study is to test the safety and effectiveness of ramucirumab in advanced, progressive carcinoid tumors. Cancer cells can make growth ...

4. academic.oup.com academic.oup.com/oncolo/article-pdf/doi/10.1093/oncolo/oyae364/61523154/oyae364.pdf

A phase II study of ramucirumab and somatostatin analog ... The primary endpoint was progression-free survival (PFS). Secondary endpoints toxicity, radiographic and biochemical tumor response rate, and ...

5. researchgate.net researchgate.net/publication/388234569_A_phase_II_study_of_ramucirumab_and_somatostatin_analog_therapy_in_patients_with_advanced_neuroendocrine_tumors?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

A phase II study of ramucirumab and somatostatin analog ... Patients were treated with ramucirumab 8 mg/kg intravenously on days 1 and 15 of each 28-day cycle. The primary endpoint was progression-free ...