CLINICAL TRIAL

Irinotecan for Cancer of Stomach

Recruiting · 18+ · All Sexes · Winston-Salem, NC

This study is evaluating whether a combination of two drugs may help treat gastric and gastroesophageal junction cancer.

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About the trial for Cancer of Stomach

Eligible Conditions
Stomach Neoplasms · Clinical Stage III Gastric Cancer AJCC v8 · Clinical Stage IVB Gastric Cancer AJCC v8 · Metastatic Gastroesophageal Junction Adenocarcinoma · Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IV Gastric Cancer AJCC v8 · Pathologic Stage IIIC Gastric Cancer AJCC v8 · Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8 · Pathologic Stage IV Gastric Cancer AJCC v8 · Unresectable Gastroesophageal Junction Adenocarcinoma · Pathologic Stage III Gastric Cancer AJCC v8 · Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Pathologic Stage IIIB Gastric Cancer AJCC v8 · Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Esophageal Neoplasms · Metastatic Gastric Adenocarcinoma · Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Unresectable Gastric Adenocarcinoma · Adenocarcinoma · Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IVA Gastric Cancer AJCC v8 · Pathologic Stage IIIA Gastric Cancer AJCC v8 · Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Irinotecan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Irinotecan
DRUG
Berzosertib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have histologically or cytologically confirmed progressive metastatic or unresectable gastric or GEJ adenocarcinoma.
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam.
Patients must have progressed after or been intolerant of at least two lines of systemic therapy. Patients with HER2 positive gastric and GEJ adenocarcinoma must have progressed on trastuzumab plus chemotherapy in the first line setting. Patients with microsatellite unstable (MSI-H) tumors must have received prior immunotherapy with pembrolizumab.
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%).
Absolute neutrophil count >= 1,500/mcL.
Platelets >= 100,000/mcL.
Hemoglobin >= 9 g/dL.
Total bilirubin within normal institutional limits.
You are of good health and of sufficient age to participate in this trial. show original
Leukocytes are 3,000 or more per microliter. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Irinotecan will improve 1 primary outcome, 4 secondary outcomes, and 6 other outcomes in patients with Cancer of Stomach. Measurement will happen over the course of From when patients achieve their best response (complete response [CR] or partial response [PR]) to when they progress or die for any reason, assessed up to 1 year.

Duration of responses (DOR)
FROM WHEN PATIENTS ACHIEVE THEIR BEST RESPONSE (COMPLETE RESPONSE [CR] OR PARTIAL RESPONSE [PR]) TO WHEN THEY PROGRESS OR DIE FOR ANY REASON, ASSESSED UP TO 1 YEAR
Will be estimated using the method of Kaplan and Meier. 95% confidence intervals for all point estimates of effect sizes (odd ratios, hazard ratios, differential pre-post biomarker expression) among subgroups will be estimated.
Time to progression (TTP)
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH FROM PROGRESSION, ASSESSED UP TO 1 YEAR
Will be estimated using the method of Kaplan and Meier. 95% confidence intervals for all point estimates of effect sizes (odd ratios, hazard ratios, differential pre-post biomarker expression) among subgroups will be estimated.
Progression-free survival (PFS)
FROM ENROLLMENT TO DISEASE PROGRESSION OR DEATH FOR ANY REASON, ASSESSED UP TO 1 YEAR
Overall survival (OS)
FROM STUDY ENROLLMENT TO DEATH FOR ANY REASON, ASSESSED UP TO 1 YEAR
Will be estimated using the method of Kaplan and Meier. 95% confidence intervals for all point estimates of effect sizes (odd ratios, hazard ratios, differential pre-post biomarker expression) among subgroups will be estimated.
Presence of other deoxyribonucleic acid (DNA) damage response defects (DDRD)
UP TO 1 YEAR
Will be summarized as frequency counts and percent of study group.
DOR in sub-cohorts based on first-line platinum sensitivity
UP TO 1 YEAR
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Patient Q & A Section

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

How many people get cancer of stomach a year in the United States?

Gastric and [esophageal cancer](https://www.withpower.com/clinical-trials/esophageal-cancer) make up 0.1-0.5% of all cancer cases in the United States. Each year, 635–715,000 Americans are diagnosed with cancer of the stomach, esophagus, or oesophageal. About 400,000 of these people will have a good chance of survival if they receive the best treatment available. Most stomach cancer treatment is performed at specialist hospitals.

Anonymous Patient Answer

What are the signs of cancer of stomach?

Signs of cancer of stomach include chronic unexplained weight loss, indigestion, abdominal pain, and constipation. If the pain is localized in the upper abdomen then malignancy is more likely. If no signs of malignancy are present, it is not necessary to perform barium enema or CT scan. If the patient has non-specific abdominal pain and weight loss, then CT scan or endoscopy should be undertaken. If the pain is localized in the lower abdomen, barium enema or CT is sufficient. If the pain is not localized, then the patient should be referred to an esophageal cancer center.

Anonymous Patient Answer

What is cancer of stomach?

Cancer of stomach or oesophagus is a serious, malignant disease that spreads rapidly and can kill its victims within two to four years. The prognosis is worse for patients with undifferentiated or poorly differentiated tumors or when the disease has metastasized, and even worse when the tumors have a high malignant potential (high grade tumor) and they have had distant metastasis.

Anonymous Patient Answer

What causes cancer of stomach?

A variety of factors may play a role in cancer development, but the precise causes remain uncertain. What has been known so far about stomach cancers and smoking? Tobacco and alcohol intake increase the risk. Poor diet, obesity, infections and cancers of the colon, bladder, cervix, oesophagus, pancreas, stomach and liver may also increase risk. Smoking, drinking tea, wine and cola beverages may protect smokers and drinkers. Diet may be protective for some groups. Poor diet and excessive drinking may also be related to colorectal cancer in people with ulcerative colitis. Obesity and alcoholism may be risk-factors for breast cancer.

Anonymous Patient Answer

What are common treatments for cancer of stomach?

Currently, few therapeutic options are available for the treatment of GC, but new targeted treatments are being developed that may have greater efficacy and tolerability than current antitumor treatments.

Anonymous Patient Answer

Can cancer of stomach be cured?

The treatment used was not useful for the improvement of QOL in cancer of stomach, but it can be suggested that radical resection is superior to endoscopic or endoscopic submucosal dissection.

Anonymous Patient Answer

How serious can cancer of stomach be?

In general, cancer of stomach is rare in patients under 50 years of age, though its prevalence increases significantly in the 80+ age group. The most common form of cancer of stomach is adenocarcinoma (40%). Risk factors for adenocarcinoma of stomach are smoking, obesity, and diabetes mellitus. Cancer of stomach can spread throughout the body. Patients with [adenocarcinoma of stomach that has metastasized at the time of diagnosis] often have more than one organ at which metastatic disease is present.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer of stomach?

There were recent discoveries in the last decade that showed that targeting cytokine production can lead to antitumor activity in stomach cancer. The mechanism that is used varies according to the origin of the tumor, but targeting cytokine-stimulated tumor production seems to be useful for achieving an antitumor effect in stomach cancer. If these findings are confirmed by future clinical trials, the cytokine inhibitors may have a future role in treating stomach cancer.

Anonymous Patient Answer

Have there been other clinical trials involving irinotecan?

The clinical trial of TAP was the first of its kind. The study has shown a very good effect, and there is a high rate of success in terms of remission and response to the treatment. However, there are no reports of other clinical studies using irinotecan. It is a pity that it was not used in the treatment of patients, but instead, its effects were studied in the research lab, to avoid any side effects.

Anonymous Patient Answer

What is the survival rate for cancer of stomach?

The present study suggests that there is a survival difference in gastric carcinoma cases based on a socio-economic status, but no such difference in cancers of other site. In addition, the rate of cure was correlated with survival; a longer survival rate was observed in gastric carcinomas where the cancer was at its early stages of onset and was localized in the mucosa.

Anonymous Patient Answer

What is the primary cause of cancer of stomach?

The present study showed that the following factors had a significance in predicting primary cause of stomach: age, gender, marital status, occupation and smoking habits. This indicates that factors other than smoking and alcohol consumption exert a significant influence on determining the primary cause of stomach cancer.

Anonymous Patient Answer

How does irinotecan work?

In addition to a high number of irinotecan molecules, the large volume of blood in a cancer patient may be a factor in irinotecan-related nephrotoxicity, and a lower intravenous dose may reduce this dose-related toxicity.

Anonymous Patient Answer
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