Overview
This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer.
Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study.
Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication.
Response evaluation will be done every 6 weeks.
Eligibility
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of bladder/urachal remnant that is clinically consistent with urachal cancer.
Origin in the anterior wall or dome of the bladder Predominant invasion of muscularis or
deeper tissues No obvious origin from the overlying urothelium (relative normal-looking
urothelial mucosa) No primary adenocarcinoma elsewhere
- Patients with locally advanced, recurrent, or metastatic disease not amenable to
surgery, radiotherapy, or combined modality therapy with curative intent
- No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous
5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim is
allowed if it ended more than 6 months before enrollment.
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status 0 or 1
- Age 19 years or older
- Adequate cardiac function
- Adequate bone marrow, hepatic, and renal function Hematology
- Life expectancy more than 3 months
- Signed and dated informed consent of document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment
- Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
- Age > 65
- Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be
permitted unless the lesion is the only measurable lesion
- Uncontrolled CNS metastasis (brain and/or leptomeningeal metastasis)
- Grade 2 or more peripheral neuropathy
- Diagnosis of any serious secondary malignancy within the last 2 years, except for
adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma
of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
- Pregnancy or breast feeding, or intention of becoming pregnant during study treatment
or within 6 months after final dose
- Other severe acute or chronic medical or psychiatric condition
- Chronic diarrhea
- Clinically significant cardiac disease (heart failure, coronary artery disease, and/or
arrhythmia)
- Hypersensitivity to study medication
- treatment with a prohibited medication or anticipation of need for prohibited
medication ( section 5.5 )