Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
- Conditions
- Esophagus cancer
- Registration Number
- JPRN-UMIN000004009
- Lead Sponsor
- Kinki University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1) During treatment or diabetes mellitus inadequate control (HbA1c merges) doing more than 6.5% with an aim by consecutive use of insulin. 2) The patient having active multiple primary cancer (synchronism multiple primary cancer and a having sound health period, metachronous multiple primary cancer within five years). But healing and judged carcinoma in situ (carcinoma in situ) or lesion of intramucosal carcinoma equivalency cannot include.In active multiple primary cancer by local treatment. 3) It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical. 4) We have active bacteria and fungal infection. (we have pyrexia more than 38 degrees Celsius, and bacterial infection is proved on an imaging or bacteriologic examination) 5) The patient who has consecutive systemic therapy (in internal use or a vein) of steroid. 6) Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy (more than CTCAE v3.0, Grade 1). 7) The patient who shows dropsy (more than CTCAE v3.0, Grade 1) regardless of presence of cause. 8) The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis. 9) The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 10) During the pregnancy or a pregnant female patient we are possible or are nursing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decision of a recommended dosage
- Secondary Outcome Measures
Name Time Method