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Lapatinib + Chemotherapy for Gastrointestinal Cancer
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance status = 2
Age =18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) until 28 days after the last dose (average of 239 days)
Awards & highlights
Study Summary
This trial will enroll patients with cancer of the stomach, esophagus, or gastro-esophageal junction whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival.
Who is the study for?
Adults with advanced gastric, esophageal, or gastro-esophageal junction cancer that is HER2 positive can join. They must have measurable disease and be in good enough health for chemotherapy. Prior treatments are okay if they were over 5 years ago or over 6 months for early-stage gastric cancer. Pregnant women, those with active brain tumors, uncontrolled diseases, recent other cancers (except some skin cancers), severe heart conditions, infections or neuropathy cannot participate.Check my eligibility
What is being tested?
The trial tests if adding lapatinib to the chemo drugs capecitabine and oxaliplatin (CapeOx) helps patients live longer without their cancer getting worse compared to just CapeOx plus a placebo. Patients will be randomly chosen to get either lapatinib or a fake pill along with standard chemo.See study design
What are the potential side effects?
Lapatinib may cause diarrhea, rash, fatigue; capecitabine can lead to hand-foot syndrome (redness/pain on palms/soles), diarrhea; oxaliplatin might trigger nerve damage like tingling in hands/feet. All these drugs together could increase the risk of infection and affect blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk and care for myself, but I am unable to do any work.
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I am 18 years old or older.
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My cancer cannot be removed by surgery, has spread, or has come back.
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My cancer is HER2 positive.
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I can take pills by mouth or through a feeding tube.
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My cancer is confirmed to be in the stomach, esophagus, or where they join.
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It has been over 4 weeks since my last radiation treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day 1) until 28 days after the last dose (average of 239 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until 28 days after the last dose (average of 239 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Overall Survival in All Randomized Participants
Secondary outcome measures
Duration of Response (DOR)
Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36
Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36
+9 moreSide effects data
From 2018 Phase 3 trial • 1286 Patients • NCT0007352860%
Diarrhoea
34%
Rash
29%
Nausea
19%
Fatigue
17%
Arthralgia
15%
Back pain
15%
Vomiting
13%
Headache
13%
Dry skin
12%
Decreased appetite
12%
Pruritus
12%
Asthenia
11%
Alopecia
11%
Cough
10%
Pain in extremity
10%
Hot flush
10%
Nail disorder
9%
Epistaxis
9%
Dyspnoea
9%
Alanine aminotransferase increased
9%
Dyspepsia
8%
Anaemia
8%
Musculoskeletal pain
8%
Aspartate aminotransferase increased
8%
Nasopharyngitis
7%
Dizziness
7%
Constipation
7%
Abdominal pain
6%
Pyrexia
6%
Paronychia
6%
Abdominal pain upper
6%
Mucosal inflammation
6%
Acne
6%
Insomnia
5%
Musculoskeletal chest pain
5%
Weight decreased
5%
Muscle spasms
5%
Stomatitis
5%
Upper respiratory tract infection
5%
Urinary tract infection
5%
Blood alkaline phosphatase increased
5%
Erythema
4%
Bone pain
4%
Myalgia
4%
Oedema peripheral
3%
Ejection fraction decreased
1%
Left ventricular dysfunction
1%
Erysipelas
1%
Dehydration
1%
Chest pain
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Letrozole 2.5 mg
Lapatinib 1500 mg + Letrozole 2.5 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CapeOx plus LapatinibExperimental Treatment3 Interventions
CapeOx plus Lapatinib
Group II: CapeOx plus PlaceboPlacebo Group3 Interventions
CapeOx plus Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lapatinib
2006
Completed Phase 3
~3530
Capecitabine
2013
Completed Phase 3
~3420
Oxaliplatin
2011
Completed Phase 4
~2560
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,808 Total Patients Enrolled
1 Trials studying Gastrointestinal Neoplasms
60 Patients Enrolled for Gastrointestinal Neoplasms
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active brain or spinal cord disease.My cancer is a type of gastric carcinoid, sarcoma, or squamous cell.I have been diagnosed with DPD deficiency.It's been over 5 years since my last cancer treatment with hormones, biologics, or immunotherapy.I do not have any health conditions that would make it unsafe for me to join the study.I have a history of serious heart issues that are not under control.I had chemotherapy for a non-stomach cancer more than 5 years ago.I can walk and care for myself, but I am unable to do any work.I had stomach surgery over 3 weeks ago and have recovered.I am 18 years old or older.I had chemotherapy for early-stage stomach cancer more than 6 months ago.I have received chemotherapy for gastric cancer to relieve symptoms.I was treated with oxaliplatin less than a year ago.My blood, kidney, and liver are functioning well.I don't have ongoing serious side effects from previous cancer treatments or experimental drugs.My cancer cannot be removed by surgery, has spread, or has come back.I have fluid buildup in my abdomen that isn't responding to treatment.I have moderate nerve damage affecting my movement or sensation.I've been cancer-free for 5 years, or had non-melanoma skin cancer removed, or had in situ carcinoma treated successfully.My cancer is HER2 positive.I do not have any infections that are not responding to treatment.I can take pills by mouth or through a feeding tube.I have a liver or bile duct condition.I do not have issues absorbing nutrients or uncontrolled gut inflammation.My cancer is confirmed to be in the stomach, esophagus, or where they join.I am willing to use birth control during the study.I am not taking any medications that would interfere with the study drugs.It has been over 4 weeks since my last radiation treatment.I am not currently receiving any cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: CapeOx plus Lapatinib
- Group 2: CapeOx plus Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are we looking for more individuals to participate in this research?
"According to the latest information on clinicaltrials.gov, this particular trial is not currently recruiting patients. Although the trial has not updated their status in a while (the last update was on 6/29/2022), there are 750 other trials that are presently looking for candidates."
Answered by AI
For what purpose is Lapatinib typically employed?
"Most often, lapatinib is used to treat metastatic colorectal carcinoma. However, it can also help patients with pancreatic endocrine carcinoma, postmenopause, and stage iii colon cancer."
Answered by AI
Are there any similar experiments that have tested Lapatinib?
"At this time, a total of 602 studies are being conducted on Lapatinib. Out of those, 203 are in Phase 3. Most of the Lapatinib trials are based in Woolloongabba, Queensland; however, there are 22240 locations running studies for this treatment."
Answered by AI
What are the researcher's hypotheses for this experiment?
"The primary outcome of this clinical trial is overall survival, which will be measured over an average of 51 weeks. Secondary objectives include duration of response (DOR) and mean change in scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) from baseline to week 36. The trial is looking for 100 patients across 3 sites."
Answered by AI
Has Lapatinib been cleared by the FDA?
"There is both prior clinical data and multiple rounds of safety testing data that support Lapatinib's safety, so it received a score of 3."
Answered by AI
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