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Anti-metabolites

Ramucirumab + Chemotherapy for Small Bowel Cancer

Phase 2

Recruiting

Led By Michael J Overman

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a Zubrod performance status of 0 or 1

Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to grade 1 (with the exception of grade 2 neuropathy) prior to registration. In Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"

Must not have

Patient must not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis

Patients must not have experienced any grade 3-4 GI bleeding within 90 days prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years after registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well ramucirumab and paclitaxel or the FOLFIRI regimen work in treating patients with small bowel cancers that have spread extensively or are no longer responding to treatment.

Who is the study for?

This trial is for patients with advanced or refractory small bowel adenocarcinoma, excluding ampullary types. Participants must have previously progressed on fluoropyrimidine and/or oxaliplatin treatments, be at least 30 days stable post-brain metastases treatment if applicable, and not have had recent major surgery. They should not be pregnant/nursing, must agree to use contraception if of reproductive potential, and cannot have certain conditions like uncontrolled hypertension or a history of significant thromboembolism.

What is being tested?

The study compares the effectiveness of Ramucirumab combined with Paclitaxel versus the FOLFIRI regimen (Fluorouracil, Leucovorin Calcium, Irinotecan Hydrochloride) in treating advanced small bowel cancers. Ramucirumab is an antibody that may inhibit tumor growth by blocking blood vessel formation while other drugs aim to kill or stop cancer cells from dividing.

What are the potential side effects?

Potential side effects include high blood pressure due to Ramucirumab; nerve damage, muscle pain from Paclitaxel; and diarrhea, low white blood cell count from FOLFIRI components. There's also a risk of bleeding complications or wound healing issues related to the anti-cancer therapies.

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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I finished my last cancer treatment over 2 weeks ago and feel mostly better, except for some moderate numbness.

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I do not have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

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My cancer is a type of small bowel adenocarcinoma that cannot be removed by surgery or has spread.

Exclusion Criteria

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

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My liver functions well, without severe disease or complications like serious fluid buildup.

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I haven't had severe GI bleeding in the last 3 months.

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I haven't had any serious wounds, ulcers, or broken bones in the last 28 days.

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I do not have a bleeding disorder.

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I have not been treated with irinotecan, taxane, or ramucirumab for small bowel cancer.

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I do not have an infection that needs treatment with medication.

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My cancer does not have mismatch repair deficiency or high microsatellite instability.

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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

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I am not on long-term blood thinner medications like clopidogrel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years after registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years after registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after registration 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

Incidence of adverse events

Overall response rate

Overall survival (OS)

Other study objectives

CEA level

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

Pain in extremity

Oropharyngeal pain

Thrombocytopenia

Rash

Nail discolouration

Dizziness

Haemoptysis

Productive cough

Pain

Dyspepsia

Dehydration

Hyperglycaemia

Dysphonia

Paraesthesia

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

2Treatment groups

Experimental Treatment

Group I: Arm II (irinotecan, leucovorin, fluorouracil)Experimental Treatment5 Interventions

Patients receive irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 2 hours on days 1 and 15, and fluorouracil IV bolus on days 1 and 15. Patients also receive fluorouracil IV over 46-48 hours on days 1-3 and 15-17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ramucirumab, paclitaxel)Experimental Treatment2 Interventions

Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15, and paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050

Ramucirumab

2017

Completed Phase 3

~5050