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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 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%
Insomnia
11%
Hypertension
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Dizziness
7%
Rash
7%
Nail discolouration
6%
Haemoptysis
6%
Pain
6%
Hyperglycaemia
6%
Dyspepsia
6%
Dehydration
6%
Dysphonia
6%
Paraesthesia
6%
Productive cough
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Lobar pneumonia
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

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
Ramucirumab
2017
Completed Phase 3
~5050
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Irinotecan
2017
Completed Phase 3
~2590
Paclitaxel
2011
Completed Phase 4
~5450
Fluorouracil
2014
Completed Phase 3
~11700
Leucovorin
2005
Completed Phase 4
~6010
Leucovorin Calcium
2011
Completed Phase 3
~12500

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,093 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
266,508 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,966 Total Patients Enrolled
2 Trials studying Small Intestinal Adenocarcinoma
848 Patients Enrolled for Small Intestinal Adenocarcinoma

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04205968 — Phase 2
Small Intestinal Adenocarcinoma Research Study Groups: Arm II (irinotecan, leucovorin, fluorouracil), Arm I (ramucirumab, paclitaxel)
Small Intestinal Adenocarcinoma Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04205968 — Phase 2
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205968 — Phase 2
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