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Monoclonal Antibodies

Ramucirumab + Somatostatin Analog for Carcinoid Tumor

Phase 2
Waitlist Available
Led By Jennifer A Chan, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have evidence of radiographic disease progression within the past 12 months. Progressive disease by RECIST criteria is not required.
ECOG performance status 0-1 (see Appendix A).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a drug to see if it can treat advanced, progressive carcinoid tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include high blood pressure, bleeding risks due to anti-angiogenic properties (which can affect blood vessel formation), possible wound healing complications, gastrointestinal issues such as ulcers or bleeding, and increased risk of arterial thromboembolic events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened in the last year, shown by scans.
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I can carry out all my usual activities without help.
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My cancer cannot be removed by surgery and has spread.
Select...
I agree to use birth control during and up to 4 months after the study.
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My blood, liver, kidney, and coagulation tests are within normal ranges.
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I have a tumor that can be measured with scans or exams.
Select...
I am 18 years old or older.
Select...
I have a confirmed low- to intermediate-grade neuroendocrine tumor, but not in the pancreas.
Select...
I have a confirmed low- to intermediate-grade neuroendocrine tumor, but not in the pancreas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Biochemical Response (Chromogranin A)
Overall Radiographic Response
Overall Survival

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973
46%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Back pain
12%
Peripheral sensory neuropathy
11%
Dysgeusia
11%
Arthralgia
11%
Insomnia
11%
Headache
11%
Hypertension
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Pain in extremity
8%
Oropharyngeal pain
8%
Thrombocytopenia
7%
Nail discolouration
7%
Dizziness
7%
Rash
6%
Pain
6%
Dyspepsia
6%
Productive cough
6%
Hyperglycaemia
6%
Paraesthesia
6%
Dysphonia
6%
Haemoptysis
6%
Dehydration
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Lobar pneumonia
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ramucirumab In Combination With Somatostatin AnalogExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,627 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,363 Total Patients Enrolled
6 Trials studying Carcinoid Tumor
218 Patients Enrolled for Carcinoid Tumor
Jennifer A Chan, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Ramucirumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02795858 — Phase 2
Carcinoid Tumor Research Study Groups: Ramucirumab In Combination With Somatostatin Analog
Carcinoid Tumor Clinical Trial 2023: Ramucirumab Highlights & Side Effects. Trial Name: NCT02795858 — Phase 2
Ramucirumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02795858 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a high risk associated with Ramucirumab?

"Ramucirumab has been evaluated in a Phase 2 trial, so while there is some evidence to support its safety, more research needs to be done to confirm its efficacy."

Answered by AI

What is the primary illness that Ramucirumab has been shown to target?

"Ramucirumab is a medication that, while typically used to treat advanced directives, can also be effective for biliary fistula, vasoactive intestinal peptide tumors, and octreotide."

Answered by AI

How many people are allowed to be a part of this clinical trial at one time?

"This study has completed recruitment for participants. The trial was first posted on 6/14/2016, with the most recent update being on 4/14/2022. For individuals looking for other trials, there are 32 studies actively enrolling patients with carcinoid tumors and 75 studies for Ramucirumab that still need participants."

Answered by AI

Are there any patients who have not yet been enrolled in this trial?

"The aforementioned website indicates that this particular clinical trial is not, at present, looking for patients to participate. Although, it is worth mentioning that there are one hundred and seven other trials which are currently open to enrolment."

Answered by AI

Who else is applying?

What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria

What questions have other patients asked about this trial?

What is the treatment schedule time frame? Have there been any serious, life-threatening side effects?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

It sounds promising for success.
PatientReceived no prior treatments
~5 spots leftby Mar 2025