All > Nebraska

Irinotecan for Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hospital Universitario Virgen del Rocio, Sevilla, SpainSmall Cell Lung CancerIrinotecan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing two different experimental treatments for small cell lung cancer that has returned after one other treatment. One experimental treatment is a single drug, and the other experimental treatment is a combination of two drugs. The trial will compare how well the experimental treatments work to a standard treatment.

Eligible Conditions
  • Small Cell Lung Cancer Relapse

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Irinotecan
1
Brigatinib
1
Ibrutinib

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At baseline and every six weeks (± one week) until end of treatment, up to 39 months

At 12 months
Overall survival rate at 12 months
Progression-free survival rate at 12 months
At 24 months
Overall survival rate at 24 months
At 6 months
Progression-free survival rate at 6 months
Month 39
Patient-reported outcomes
Month 39
Duration of response
Month 39
Overall response rate
Overall survival
Month 39
Progression-free survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Irinotecan
1
Brigatinib
1
Ibrutinib

Side Effects for

Bevacizumab: Phase A and Phase B
68%Nausea
63%Fatigue
63%Neuropathy peripheral
55%Diarrhoea
40%Constipation
31%Abdominal pain
30%Palmar-plantar erythrodysaesthesia syndrome
28%Vomiting
25%Neutropenia
24%Mucosal inflammation
23%Epistaxis
22%Decreased appetite
20%Insomnia
20%Paraesthesia
20%Gastrooesophageal reflux disease
20%Alopecia
19%Headache
18%Hypertension
17%Stomatitis
17%Back pain
16%Dysgeusia
16%Rash
16%Urinary tract infection
14%Pain in extremity
14%Upper respiratory tract infection
13%Mouth ulceration
13%Thrombocytopenia
13%Arthralgia
12%Dysaesthesia
12%Anaemia
11%Weight decreased
11%Musculoskeletal pain
11%Oedema peripheral
10%Cough
10%Dyspnoea
10%Pulmonary embolism
10%Abdominal pain upper
10%Dizziness
10%Dyspepsia
9%Depression
9%Dysphonia
9%Pyrexia
8%Fall
8%Anxiety
8%Proteinuria
8%Dry skin
7%Abdominal distension
7%Rectal haemorrhage
7%Lethargy
7%Toothache
7%Neck pain
6%Non-cardiac chest pain
6%Dehydration
6%Rhinorrhoea
6%Oropharyngeal pain
5%Muscle spasms
5%Intestinal obstruction
5%Oral herpes
5%Sepsis
5%Nail disorder
5%Hypotension
5%Haemorrhoids
5%Oral candidiasis
5%Hypoalbuminaemia
5%Hypokalaemia
2%Angina pectoris
2%Small intestinal obstruction
2%Flank pain
2%Enterovesical fistula
2%Pneumonia
2%Febrile neutropenia
2%Gastroenteritis
2%Lower respiratory tract infection
2%Anal abscess
2%Bronchitis
2%Renal failure acute
2%Confusional state
1%Thrombophlebitis superficial
1%Anal fissure
1%Visual impairment
1%Colitis
1%Gastritis
1%Ileus
1%Inguinal hernia
1%Intestinal perforation
1%Large intestinal obstruction
1%Large intestine perforation
1%Melaena
1%Neutropenic colitis
1%Catheter site pain
1%Enterocolitis infectious
1%Eyelid infection
1%Infusion related reaction
1%Hypophagia
1%Urinary incontinence
1%Pneumonia aspiration
1%Rectal perforation
1%Dysphagia
1%Colonic obstruction
1%Haematuria
1%Gangrene
1%Urosepsis
1%Pneumonia streptococcal
1%Radius fracture
1%Musculoskeletal chest pain
1%Procedural pain
1%Cerebrovascular accident
1%Extravasation
1%Gastrointestinal perforation
1%Gastrointestinal haemorrhage
1%Cholecystitis acute
1%Infective exacerbation of chronic obstructive airways disease
1%Abscess limb
1%Lobar pneumonia
1%Pilonidal cyst
1%Ear infection
1%Wound infection
1%Procedural site reaction
1%Hemiparesis
1%Clostridium difficile colitis
1%Device related infection
1%Muscle abscess
1%Pleural effusion
1%Pharyngitis
1%Laceration
1%Hypomagnesaemia
1%Infected dermal cyst
1%Gastroenteritis viral
1%Syncope
1%Transient ischaemic attack
1%Acute psychosis
1%Pleuritic pain
1%Hydronephrosis
1%Jugular vein thrombosis
1%Orthostatic hypotension
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01588990) in the Bevacizumab: Phase A and Phase B ARM group. Side effects include: Nausea with 68%, Fatigue with 63%, Neuropathy peripheral with 63%, Diarrhoea with 55%, Constipation with 40%.

Trial Design

3 Treatment Groups

Control arm
1 of 3
Lurbinectedin plus Irinotecan
1 of 3
Lurbinectedin
1 of 3

Active Control

Experimental Treatment

705 Total Participants · 3 Treatment Groups

Primary Treatment: Irinotecan · No Placebo Group · Phase 3

Lurbinectedin plus IrinotecanExperimental Group · 2 Interventions: Irinotecan, Lurbinectedin · Intervention Types: Drug, Drug
Lurbinectedin
Drug
Experimental Group · 1 Intervention: Lurbinectedin · Intervention Types: Drug
Control armActiveComparator Group · 2 Interventions: Topotecan, Irinotecan · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Lurbinectedin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline and every six weeks (± one week) until end of treatment, up to 39 months

Who is running the clinical trial?

PharmaMarLead Sponsor
86 Previous Clinical Trials
10,565 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You have had radiation therapy in the past, but it has been at least two weeks since your last treatment for your brain or any other part of your body.
References

Frequently Asked Questions

Are there other ways in which Irinotecan has been studied?

"663 clinical trials have been completed for irinotecan since 2002, when it was first studied at Mayo Clinic. As of now, there are 336 active studies being conducted, a large portion of which are based in Toronto and North Carolina." - Anonymous Online Contributor

Unverified Answer

Are there vacancies in this trial for new participants?

"Yes, this clinical trial is still looking for participants. The most recent update on clinicaltrials.gov was on November 3rd, 2022 and the trial was originally posted on July 22nd of the same year." - Anonymous Online Contributor

Unverified Answer

What has been the most common side effect in people who have taken Irinotecan?

"There is some clinical evidence to support the efficacy of irinotecan, as well as numerous rounds of data collected to support its safety. Consequently, we have rated irinotecan as a 3 on our safety scale." - Anonymous Online Contributor

Unverified Answer

At how many different hospitals is this clinical trial taking place?

"University Health Network - Princess Margaret Hospital in Toronto, North Carolina, FirstHealth Outpatient Cancer Center in Pinehurst, Illinois, and McGill University Health Centre (MUHC) in Montréal, Massachusetts are all locations where this study is recruiting patients. In addition, there are 6 other sites." - Anonymous Online Contributor

Unverified Answer

What conditions does Irinotecan treat most often?

"Most often, irinotecan is used to treat leukemia, myelocytic, and acute conditions. However, it has also been known to be effective in treating colorectal carcinoma, ovarian cancer, and sarcoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top