Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
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
1 other identifier
interventional
41
1 country
11
Brief 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 advanced gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 gastric-cancer
Started Oct 2003
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 10, 2003
CompletedFirst Posted
Study publicly available on registry
November 13, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedSeptember 3, 2024
August 1, 2024
2.4 years
November 10, 2003
August 30, 2024
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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.
- +2 more criteria
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Rosen, Lee
Los Angeles, California, 90025, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90089, United States
Chong, Clayton
Honolulu, Hawaii, 96817, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96817, United States
Northwestern University Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Lovelace Sandia Health System
Albuquerque, New Mexico, 87108, United States
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108, United States
University of New Mexico - Albuquerque
Albuquerque, New Mexico, 87131, United States
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2003
First Posted
November 13, 2003
Study Start
October 1, 2003
Primary Completion
March 1, 2006
Study Completion
May 1, 2006
Last Updated
September 3, 2024
Record last verified: 2024-08