Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
Completed · Phase 1/Phase 2
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT00072787
- Run by
- Taiho Oncology, Inc.
- People needed
- 41
- Starts
- 2003-10-01
- Expected to finish
- 2006-05-01
- Last updated by the study team
- 2024-09-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
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.
Where it is running
- Rosen, Lee — Los Angeles, California, United States
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Chong, Clayton — Honolulu, Hawaii, United States
- Straub Clinic and Hospital — Honolulu, Hawaii, United States
- Northwestern University Robert H Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Lovelace Sandia Health System — Albuquerque, New Mexico, United States
- New Mexico VA Health Care System — Albuquerque, New Mexico, United States
- University of New Mexico - Albuquerque — Albuquerque, New Mexico, United States
- Abramson Cancer Center at the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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