Gastric CancerPhase 1/2NCT00072787
Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
A Phase 1/2 study testing S-1 and cisplatin in people with Gastric Cancer, run by Taiho Oncology, Inc. at 11 sites in United States.
Trial summary
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients. The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1 and cisplatin
- How many people
- 41 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2003to May 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Has advanced, unresectable cancer at the time of study entry
- Has measurable disease as defined by RECIST criteria, i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scan
- Is at least 3 weeks post-gastrectomy surgery
- Has not received prior chemotherapy for their cancer (adjuvant therapy is permitted and does not count as prior chemotherapy).
- Has performance status of ≥ 70% on the Karnofsky scale (Appendix B)
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- Has a predicted life expectancy of ≥ 12 weeks
- Has an absolute granulocyte count of ≥ 1,500/mm3
- Has a platelet count ≥ 100,000/mm3
- Has a hemoglobin of ≥ 9.0 g/dL
- Has a bilirubin of ≤ 1.5 times the ULN
- Has transaminases ≤ 2.5 times the ULN except for patients with liver metastasis who may have transaminases ≤ 5 times the ULN
- Has a creatinine ≤ ULN and calculated creatinine ≥ 60 mL/min
- According to the judgment of the Investigator, the patient has recovered from all previous anti-cancer treatment-related toxicities to at least Grade 1 (see exceptions above)
- Has stopped all previous investigational drugs at least 4 weeks prior to treatment with S-1 and cisplatin.
- Is able to take medications orally
- Female patients of childbearing potential who are not pregnant and who use acceptable means of contraception while on study and for an additional 30 days after the last dose of study medication. Male patients must use adequate contraception.
Who cannot join
- Has relapsed within 6 months from the end of adjuvant therapy
- Has known brain or leptomeningeal metastases.
- Has any other serious illness or medical condition(s) including, but not limited to, the following:
- uncontrolled congestive heart failure, angina pectoris, arrhythmias, or hypertension ; or any significant medical condition that is a contraindication for chemotherapy
- concurrent malignancy other than gastric cancer except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer
- active infection
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- gastrointestinal disorder, including malabsorption, chronic nausea and vomiting, chronic diarrhea
- unstable diabetes mellitus
- psychiatric disorder that may interfere with consent and/or protocol compliance
- known neuropathy (including hearing loss) at baseline of Grade 2 or higher (as per NCI CTC v2.0 see Appendix A)
- Has known hypersensitivity to any of the constituents of the study medication
- Is receiving a concomitant treatment with drugs interacting with S-1.
- Is a pregnant or lactating female or who refuses to use an acceptable means of contraception. Is a male and refuses to use an acceptable means of contraception.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lovelace Sandia Health System
Albuquerque, New Mexico, 87108
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
University of New Mexico - Albuquerque
Albuquerque, New Mexico, 87131
Northwestern University Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Chong, Clayton
Honolulu, Hawaii, 96817
Straub Clinic and Hospital
Honolulu, Hawaii, 96817
MD Anderson Cancer Center
Houston, Texas, 77030
Rosen, Lee
Los Angeles, California, 90025
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients.
The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.
Read the detailed description
S-1 is an oral fluoropyrimidine which combines tegafur (a 5-FU prodrug) with two classes of modulators which:
- inhibit dihydropyrimidine dehydrogenase (DPD) and
- block phosphorylation of 5-FU in gastrointestinal tissues.
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity.
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer.
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer.
- Conditions
- Gastric Cancer
- Being tested
- S-1, cisplatin
- Keywords
- gastric cancer, phase 2 clinical trial
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
cisplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2003 (estimated)
- Study startOct 2003
- Primary completionMar 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072787
- Sponsor's protocol ID
- TPU-S1101; ID02-694
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2003
- Last updated
- 3 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00072787
- Acronym / sponsor ID
- TPU-S1101; ID02-694
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, phase 2 clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 13 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients.
The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.
Detailed description
S-1 is an oral fluoropyrimidine which combines tegafur (a 5-FU prodrug) with two classes of modulators which:
- inhibit dihydropyrimidine dehydrogenase (DPD) and
- block phosphorylation of 5-FU in gastrointestinal tissues.
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity.
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer.
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Has histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Has advanced, unresectable cancer at the time of study entry
- Has measurable disease as defined by RECIST criteria, i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scan
- Is at least 3 weeks post-gastrectomy surgery
- Has not received prior chemotherapy for their cancer (adjuvant therapy is permitted and does not count as prior chemotherapy).
Key exclusion criteria (13 listed)
- Has relapsed within 6 months from the end of adjuvant therapy
- Has known brain or leptomeningeal metastases.
- Has any other serious illness or medical condition(s) including, but not limited to, the following:
- Has known hypersensitivity to any of the constituents of the study medication
- Is receiving a concomitant treatment with drugs interacting with S-1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 | Drug | – |
| cisplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-1 and cisplatin in people with Gastric Cancer, run by Taiho Oncology, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.