Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
- Conditions
- advanced gastric cancer
- Registration Number
- JPRN-UMIN000015595
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1)Chemotherapy, radiation therapy or other investigational drugs within 2 weeks prior to enrollment. 2)Active bleeding. 3)Patient with any of the following symptoms within 6 months prior to administration of the drug;myocardial infarction, severe or unstable angina, congested heart failure,cerebrovascular accident containing transient ischemic attack or pulmonary embolism. 4)Uncontrolled bronchial asthma. 5)Patient with brain metastases. 6)Laparotomy or thoracotomy within 4 weeks to enrollment. 7)Known hypersensitivity to sulfa drugs or acetylsalicylic acid formulation. 8)Known history of serious adverse events due to cisplatin 9)Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility. 10)Patient is judged by the investigator to be inappropriate for study participation for any reason. 11)Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of dose limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Adverse event : AE Response rate: RR Progression free survival: PFS