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Topoisomerase I inhibitor
Irinotecan in Treating Patients With Advanced Cancer of the Stomach
Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced cancer of the stomach.
Eligible Conditions
- Esophageal Cancer
- Stomach Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 2 trial • 213 Patients • NCT0149828972%
Fatigue
71%
Anemia
69%
Diarrhea
63%
Nausea
52%
Hypoalbuminemia
47%
Anorexia
45%
Vomiting
42%
White blood cell decreased
41%
Abdominal pain
37%
Hyperglycemia
36%
Hyponatremia
36%
Dehydration
35%
Hypocalcemia
34%
Constipation
33%
Weight loss
32%
Hypokalemia
32%
Alkaline phosphatase increased
31%
Neutrophil count decreased
31%
Alopecia
29%
Aspartate aminotransferase increased
27%
Lymphocyte count decreased
26%
Edema limbs
23%
Dysphagia
21%
Cough
20%
Alanine aminotransferase increased
20%
Dizziness
20%
Dyspnea
19%
Dysgeusia
19%
Hypotension
18%
Peripheral sensory neuropathy
17%
Generalized muscle weakness
16%
Anxiety
15%
Hypertension
13%
Insomnia
13%
Creatinine increased
12%
Fever
12%
Platelet count decreased
12%
Arthralgia
12%
Back pain
10%
Dry skin
10%
Blood bilirubin increased
9%
Hypomagnesemia
9%
Mucositis oral
9%
Sinus tachycardia
9%
Depression
9%
Headache
8%
Flatulence
7%
Rash maculo-papular
7%
Thromboembolic event
7%
CD4 lymphocytes decreased
7%
Hyperkalemia
7%
Hiccups
7%
Dyspepsia
6%
Pleural effusion
6%
Non-cardiac chest pain
6%
Sepsis
6%
Pruritus
6%
Pain in extremity
6%
Esophagitis
6%
Allergic rhinitis
6%
Febrile neutropenia
6%
Pain
5%
Hyperhidrosis
5%
Chills
5%
Neoplasms benign, malignant and unspecified - Other
5%
Upper respiratory infection
5%
Myalgia
5%
Watering eyes
5%
Epistaxis
5%
Rash acneiform
5%
Bloating
4%
Productive cough
4%
Esophageal pain
4%
Gastroesophageal reflux disease
4%
Hypoglycemia
4%
Hypophosphatemia
4%
Nail discoloration
4%
Blurred vision
4%
Ascites
4%
Infections and infestations-Other
4%
Nail ridging
4%
Hypernatremia
4%
Syncope
4%
Death NOS
4%
Stomach pain
4%
Skin infection
3%
Paresthesia
3%
Urinary frequency
3%
Voice alteration
3%
Dry eye
3%
Tooth infection
3%
Acute kidney injury
3%
Bone pain
3%
Metabolism and nutrition disorders - Other, specify
3%
Abdominal distension
3%
Glucose intolerance
3%
Chronic kidney disease
3%
Sore throat
3%
Dry mouth
3%
Eye disorders-Other
3%
Gastrointestinal disorders-Other
3%
Fall
3%
Allergic reaction
3%
INR increased
2%
Urinary retention
2%
Confusion
2%
Activated partial thromboplastin time prolonged
2%
Ataxia
2%
Memory impairment
2%
Oral pain
2%
Investigations-Other
2%
Muscle weakness lower limb
2%
Multi-organ failure
2%
Hypoxia
2%
Respiratory failure
2%
Upper gastrointestinal hemorrhage
2%
Lung infection
2%
Mucosal infection
2%
Weight gain
2%
Hypercalcemia
2%
Dysphasia
2%
Nasal congestion
2%
Nail loss
2%
Infusion related reaction
2%
Sinus pain
2%
Leukocytosis
2%
Ileus
2%
Proteinuria
2%
Palmar-plantar erythrodysesthesia syndrome
2%
Hot flashes
2%
Lipase increased
2%
Tremor
2%
Gastrointestinal pain
2%
Edema face
2%
Cholesterol high
2%
Malaise
2%
Localized edema
2%
Bladder infection
1%
Atelectasis
1%
Pneumonitis
1%
Hypersomnia
1%
Bronchopulmonary hemorrhage
1%
Pleuritic pain
1%
Serum amylase increased
1%
Nipple deformity
1%
Resp, thoracic and mediastinal disorders - Other
1%
Hypermagnesemia
1%
Urticaria
1%
Heart failure
1%
Eye infection
1%
Hemorrhoids
1%
Jejunal stenosis
1%
Sinus disorder
1%
Sinus bradycardia
1%
Endocrine disorders-Other
1%
Gastric hemorrhage
1%
Gallbladder pain
1%
Otitis media
1%
Ejection fraction decreased
1%
Chest wall pain
1%
Joint effusion
1%
Cognitive disturbance
1%
Pain of skin
1%
Flushing
1%
Hematoma
1%
Portal vein thrombosis
1%
Hearing impaired
1%
Fecal incontinence
1%
Obstruction gastric
1%
Enterocolitis infectious
1%
Urinary tract infection
1%
Injection site reaction
1%
Buttock pain
1%
Peripheral motor neuropathy
1%
Muscle weakness upper limb
1%
Hypothyroidism
1%
Anal fistula
1%
Tumor pain
1%
Esophageal hemorrhage
1%
Gastritis
1%
Musculoskeletal and connective tiss disorder - Other
1%
Neck pain
1%
Testicular pain
1%
Aspiration
1%
Hoarseness
1%
Pharyngeal mucositis
1%
Wheezing
1%
Skin ulceration
1%
Depressed level of consciousness
1%
Postnasal drip
1%
Vitreous hemorrhage
1%
Vascular disorders-Other
1%
Gastroparesis
1%
Malabsorption
1%
Edema trunk
1%
Small intestinal obstruction
1%
Rhinitis infective
1%
Tracheitis
1%
Gait disturbance
1%
Peritoneal infection
1%
Vascular access complication
1%
Wound infection
1%
Lip infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II IT
Arm I FOLFOX
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: irinotecanExperimental Treatment1 Intervention
Patients receive irinotecan (CPT-11) by IV over 90 minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects. Patient is taken off study if they do not recover from toxic effects, unless cause is documented to be unrelated to CPT-11. Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity. Patients with complete response continue on treatment for another 2 courses and then are observed.
Patients are followed every 3 months for 3 years or until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,510 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
222,267 Total Patients Enrolled
Richard M. Goldberg, MDStudy ChairMayo Clinic
4 Previous Clinical Trials
1,953 Total Patients Enrolled