Ramucirumab for Metastatic Small Intestinal Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Small Intestinal Adenocarcinoma+4 MoreRamucirumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Metastatic Small Intestinal Adenocarcinoma
  • Stage IIIB Small Intestinal Adenocarcinoma
  • Stage IIIA Small Intestinal Adenocarcinoma
  • Stage IV Small Intestinal Adenocarcinoma
  • Small Intestinal Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 years after registration

Year 3
Overall survival (OS)
Year 3
Progression free survival (PFS)
Year 3
CEA level
Incidence of adverse events
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Ramucirumab and Docetaxel
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%Pyrexia
16%Mucosal inflammation
14%Febrile neutropenia
14%Vomiting
14%Lacrimation increased
13%Myalgia
13%Leukopenia
12%Peripheral sensory neuropathy
12%Back pain
11%Dysgeusia
11%Headache
11%Insomnia
11%Arthralgia
11%Weight decreased
11%Asthenia
11%Hypertension
9%White blood cell count decreased
9%Abdominal pain
8%Pain in extremity
8%Thrombocytopenia
8%Oropharyngeal pain
7%Dizziness
7%Nail discolouration
7%Rash
6%Paraesthesia
6%Dysphonia
6%Pneumonia
6%Pain
6%Platelet count decreased
6%Hyperglycaemia
6%Dehydration
6%Dyspepsia
6%Haemoptysis
6%Productive cough
5%Bone pain
1%General physical health deterioration
1%Pneumothorax
1%Metastatic pain
1%Death
1%Hyponatraemia
1%Syncope
1%Confusional state
1%Chronic obstructive pulmonary disease
1%Renal failure acute
1%Pleural effusion
1%Pulmonary embolism
1%Pulmonary haemorrhage
1%Atrial fibrillation
1%Lobar pneumonia
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT01168973) in the Ramucirumab and Docetaxel ARM group. Side effects include: Fatigue with 46%, Neutropenia with 36%, Diarrhoea with 32%, Decreased appetite with 30%, Nausea with 27%.

Trial Design

2 Treatment Groups

Arm II (irinotecan, leucovorin, fluorouracil)
1 of 2
Arm I (ramucirumab, paclitaxel)
1 of 2

Experimental Treatment

94 Total Participants · 2 Treatment Groups

Primary Treatment: Ramucirumab · No Placebo Group · Phase 2

Arm II (irinotecan, leucovorin, fluorouracil)Experimental Group · 5 Interventions: Irinotecan Hydrochloride, Fluorouracil, Irinotecan, Leucovorin, Leucovorin Calcium · Intervention Types: Drug, Drug, Drug, Drug, Drug
Arm I (ramucirumab, paclitaxel)Experimental Group · 2 Interventions: Ramucirumab, Paclitaxel · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Lexatumumab
Not yet FDA approved
Fluorouracil
FDA approved
Irinotecan
FDA approved
Paclitaxel
FDA approved
Leucovorin
FDA approved
Calcium
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years after registration

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,761 Total Patients Enrolled
3 Trials studying Metastatic Small Intestinal Adenocarcinoma
127 Patients Enrolled for Metastatic Small Intestinal Adenocarcinoma
Southwest Oncology GroupLead Sponsor
386 Previous Clinical Trials
261,559 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorSouthwest Oncology Group
5 Previous Clinical Trials
224 Total Patients Enrolled
1 Trials studying Metastatic Small Intestinal Adenocarcinoma
15 Patients Enrolled for Metastatic Small Intestinal Adenocarcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A patient must have a Zubrod performance status of either 0 or 1 in order to be a candidate for a stem cell transplant.
The total bilirubin must be less than 1.5 times the institutional limit for normal
Someone who has had cancer before and has been treated with a certain kind of drug, either to keep the cancer from spreading or to try to cure it, is allowed to participate in this study
Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration
Before someone can register as a patient, they need to have a complete medical history and physical exam
The patient must have an absolute neutrophil count (ANC) of at least 1,500/mcL within the 28 days prior to registration.
No platelet transfusions in the 7 days prior to registration Platelets must be ≥ 100,000/mcL (obtained within 28 days prior to registration)
Patients must have histologically or cytologically confirmed small bowel adenocarcinoma