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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

ECOG performance status 0-1 (see Appendix A).

Locally advanced, unresectable or metastatic disease.

Must not have

Patients with symptomatic cholelithiasis.

Patients with any Grade 3-4 gastrointestinal bleeding within 3 months prior to enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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I can carry out all my usual activities without help.

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My cancer cannot be removed by surgery and has spread.

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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.

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I am 18 years old or older.

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I have a confirmed low- to intermediate-grade neuroendocrine tumor, but not in the pancreas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have painful gallstones.

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

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I have had a serious blood clot in the last 3 months.

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I haven't had a heart attack or stroke in the last 6 months.

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I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.

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I have a major surgery planned during the trial.

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I do not have severe health issues that could interfere with the study.

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I am not pregnant or breastfeeding.

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I do not have uncontrolled brain or spinal cord cancer that needs steroids.

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I am on daily aspirin or similar blood thinners, but no more than 325 mg/day.

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I have severe liver disease, with complications like confusion or fluid in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

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%

Headache

11%

Arthralgia

11%

Dysgeusia

11%

Hypertension

11%

Insomnia

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Oropharyngeal pain

Pain in extremity

Thrombocytopenia

Rash

Nail discolouration

Dizziness

Haemoptysis

Pain

Hyperglycaemia

Dyspepsia

Dehydration

Dysphonia

Paraesthesia

Productive cough

Pneumonia

Platelet count decreased

Bone pain

Chronic obstructive pulmonary disease

Hyponatraemia

Lobar pneumonia

Metastatic pain

Pleural effusion

Pneumothorax

Pulmonary embolism

Pulmonary haemorrhage

Syncope

Confusional state

Death

Atrial fibrillation

General physical health deterioration

Renal failure acute

100%

80%

60%

40%

20%

Study treatment Arm

Ramucirumab and Docetaxel

Placebo and Docetaxel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met