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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
Must not have
Known history of active CNS disease
Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma
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

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active brain or spinal cord disease.
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My cancer is a type of gastric carcinoid, sarcoma, or squamous cell.
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I have been diagnosed with DPD deficiency.
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I have a history of serious heart issues that are not under control.
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I have received chemotherapy for gastric cancer to relieve symptoms.
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I don't have ongoing serious side effects from previous cancer treatments or experimental drugs.
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I have fluid buildup in my abdomen that isn't responding to treatment.
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I have moderate nerve damage affecting my movement or sensation.
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I do not have any infections that are not responding to treatment.
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I have a liver or bile duct condition.
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I do not have issues absorbing nutrients or uncontrolled gut inflammation.
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I am not taking any medications that would interfere with the study drugs.
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I am not currently receiving any cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) until 28 days after the last dose (average of 239 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until 28 days after the last dose (average of 239 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Overall Survival in All Randomized Participants
Secondary study objectives
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 more

Side effects data

From 2018 Phase 3 trial • 1286 Patients • NCT00073528
60%
Diarrhoea
34%
Rash
29%
Nausea
19%
Fatigue
17%
Arthralgia
15%
Vomiting
15%
Back pain
13%
Headache
13%
Dry skin
12%
Asthenia
12%
Decreased appetite
12%
Pruritus
11%
Cough
11%
Alopecia
10%
Pain in extremity
10%
Nail disorder
10%
Hot flush
9%
Dyspnoea
9%
Alanine aminotransferase increased
9%
Epistaxis
9%
Dyspepsia
8%
Anaemia
8%
Nasopharyngitis
8%
Aspartate aminotransferase increased
8%
Musculoskeletal pain
7%
Abdominal pain
7%
Constipation
7%
Dizziness
6%
Insomnia
6%
Abdominal pain upper
6%
Mucosal inflammation
6%
Pyrexia
6%
Acne
6%
Paronychia
5%
Stomatitis
5%
Upper respiratory tract infection
5%
Urinary tract infection
5%
Blood alkaline phosphatase increased
5%
Weight decreased
5%
Muscle spasms
5%
Musculoskeletal chest pain
5%
Erythema
4%
Bone pain
4%
Myalgia
4%
Oedema peripheral
3%
Ejection fraction decreased
1%
Left ventricular dysfunction
1%
Chest pain
1%
Erysipelas
1%
Dehydration
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
~3970
Oxaliplatin
2011
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,459 Total Patients Enrolled
1 Trials studying Gastrointestinal Neoplasms
60 Patients Enrolled for Gastrointestinal Neoplasms

Media Library

Capecitabine Clinical Trial Eligibility Overview. Trial Name: NCT00680901 — Phase 3
Gastrointestinal Neoplasms Research Study Groups: CapeOx plus Lapatinib, CapeOx plus Placebo
Gastrointestinal Neoplasms Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT00680901 — Phase 3
Capecitabine 2023 Treatment Timeline for Medical Study. Trial Name: NCT00680901 — Phase 3
~32 spots leftby Sep 2025
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