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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)"
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years after registration
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
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
Incidence of adverse events
Overall response rate
Overall survival (OS)
Other outcome measures
CEA level
Side effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
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%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Nail discolouration
7%
Rash
7%
Dizziness
6%
Dehydration
6%
Pain
6%
Haemoptysis
6%
Dyspepsia
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
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
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
~1940
Ramucirumab
2017
Completed Phase 3
~5050
Irinotecan
2017
Completed Phase 4
~2680
Paclitaxel
2011
Completed Phase 4
~5380
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Leucovorin Calcium
2011
Completed Phase 3
~12310
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,717 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,076 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,760 Total Patients Enrolled
2 Trials studying Small Intestinal Adenocarcinoma
848 Patients Enrolled for Small Intestinal Adenocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver functions well, without severe disease or complications like serious fluid buildup.I have another cancer type, but it won't affect this trial's treatment.I have not had a heart attack or stroke in the last 4 months.I haven't had severe GI bleeding in the last 3 months.I haven't had any serious wounds, ulcers, or broken bones in the last 28 days.I can carry out all my usual activities without help.My blood pressure is well-controlled under 160/100 mmHg.My liver function tests are within the required range.I am not pregnant or nursing, have a recent negative pregnancy test, and will use effective birth control.I have not had any GI perforation or similar issues in the last 4 months.I do not have a bleeding disorder.I've had a full medical check-up in the last 28 days.My cancer's size or presence can be tracked, and I've had recent scans.I finished my last cancer treatment over 2 weeks ago and feel mostly better, except for some moderate numbness.I have not been treated with irinotecan, taxane, or ramucirumab for small bowel cancer.I do not have an infection that needs treatment with medication.My kidney function tests are within the required range.I do not have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I haven't had serious blood clots like DVT or PE in the last 3 months.My recent urine test shows low protein levels.My cancer has worsened after treatment with fluoropyrimidine or oxaliplatin.My cancer does not have mismatch repair deficiency or high microsatellite instability.My cancer is a type of small bowel adenocarcinoma that cannot be removed by surgery or has spread.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.My brain cancer has been stable for 30 days after treatment, and I haven't taken steroids for 7 days.I am not on long-term blood thinner medications like clopidogrel.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (irinotecan, leucovorin, fluorouracil)
- Group 2: Arm I (ramucirumab, paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Ramucirumab for clinical use?
"Ramucirumab was assigned a score of 2 based on the available evidence from Phase 2 trials, which points to an acceptable level of safety but yet to be proven efficacy."
Answered by AI
Are there any analogous assessments involving Ramucirumab?
"Ramucirumab was initially empirically studied in 1997 by the City of Hope Comprehensive Cancer Center; these investigations have resulted in 2274 completed clinical trials. At present, there are 1303 studies actively enrolling patients, with a considerable portion taking place within Las Vegas."
Answered by AI
How many individuals are participating in the clinical trial?
"This trial requires 94 eligible participants, who can opt to join from multiple medical centres including Comprehensive Cancer Centers of Nevada - Northwest in Las Vegas and Providence Regional Cancer System-Lacey in Lacey, Washington."
Answered by AI
Are potential participants still able to join this experiment?
"According to the information on clinicaltrials.gov, this trial is currently engaging participants. The initial posting of the study was posted December 16th 2019 and had a most recent update September 6th 2022."
Answered by AI
To what maladies is Ramucirumab typically prescribed?
"Ramucirumab is an ideal therapeutic option for those with locally advanced non-small cell lung cancer, metastatic bladder cancer or kidney failure."
Answered by AI
Who else is applying?
What site did they apply to?
SIH Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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