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Topoisomerase I inhibitor
Nitrocamptothecin for Stomach Cancer
Phase 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
Mediastinal or hilar lymph nodes must be at least 1.5 cm in diameter by CT or MRI scan to be considered measurable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the effectiveness of nitrocamptothecin in treating stomach cancer.
Who is the study for?
This trial is for adults over 18 with advanced stomach or gastroesophageal cancer that can't be surgically removed. Participants may have had limited prior treatment but must show disease progression. They should not have brain metastases, serious heart conditions, or other uncontrolled illnesses and must not be pregnant.Check my eligibility
What is being tested?
The effectiveness of nitrocamptothecin, a chemotherapy drug, is being tested on patients with advanced stomach cancer that cannot be removed by surgery. This phase II trial aims to see if the drug can stop tumor cells from growing or cause them to die.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects of chemotherapy drugs like nitrocamptothecin may include nausea, vomiting, diarrhea, fatigue, low blood cell counts leading to increased infection risk and bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the stomach or where the stomach meets the esophagus and cannot be removed by surgery.
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My lymph nodes are at least 1.5 cm big as shown by a scan.
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I do not have cancer that has spread to my brain.
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I am 18 years old or older.
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I am fully active or able to carry on all pre-disease activities without restriction.
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My bilirubin levels are 1.5 mg/dL or lower and I don't have Gilbert's syndrome.
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My kidney function is normal, and my calcium levels are not too high.
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I don't have bowel blockage, severe diarrhea, and can swallow.
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I don't have severe heart disease and haven't had a heart attack or heart failure in the last 6 months.
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I have had only one or no prior cancer treatments with immunotherapy or chemotherapy.
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My cancer has not spread to the bones only.
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
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Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,961 Total Patients Enrolled
Show-Li Sun, MDStudy ChairAstex Pharmaceuticals, Inc.
7 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the stomach or where the stomach meets the esophagus and cannot be removed by surgery.It's been over 4 weeks since my last chemotherapy and I've recovered.I have not had radiation on my only cancer sign.It's been over 4 weeks since my last radiotherapy and I've recovered.I had minor surgery over a week ago and have recovered.I am not taking phenytoin, phenobarbital, or any seizure prevention drugs.I don't have bowel blockage, severe diarrhea, and can swallow.I don't have severe heart disease and haven't had a heart attack or heart failure in the last 6 months.My condition initially responded to treatment but has since worsened.My lymph nodes are at least 1.5 cm big as shown by a scan.I do not have cancer that has spread to my brain.I am 18 years old or older.I am fully active or able to carry on all pre-disease activities without restriction.My bilirubin levels are 1.5 mg/dL or lower and I don't have Gilbert's syndrome.My kidney function is normal, and my calcium levels are not too high.I have had only one or no prior cancer treatments with immunotherapy or chemotherapy.My cancer has not spread to the bones only.I have not taken drugs like irinotecan for my condition.I am not receiving any other chemotherapy treatments.I haven't had radiation therapy on my pelvis or lower back.I am not currently undergoing radiotherapy.It's been over 3 weeks since my last major surgery and I've recovered.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is there any opportunity to become involved in this experiment?
"This trial is not currently enrolling participants, having last been updated in December 2013. Nonetheless, clinicaltrials.gov lists 891 other trials actively looking for volunteers to enter their programs."
Answered by AI
Does this intervention have the endorsement of the Food and Drug Administration?
"The evaluation of this treatment's safety has been assessed as a 2 on the 1-3 scale. This is due to its status as a Phase 2 study, which implies that while there are indications of security, efficacy has yet to be proven."
Answered by AI
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