Clinical trial NCT04611724: A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
Official title: A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urachal Cancer
Keywords: Urachal Cancer
FOLFIRINOX
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
name: Boryung Pharmaceutical Co., Ltd
First posted: 2020-11-02
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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 )

Primary outcomes:
measure: Objective response rate
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: every 2 weeks up to 30 weeks.
measure: Progression-free survival (PFS)
timeFrame: up to 2years.
measure: Overall survival (OS),
timeFrame: up to 5 years.
measure: Incidence of febrile neutropenia
timeFrame: After study completion (an average of 2 year)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jae -Lyun Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N, Miyashita K, Mizuno N, Tsuji K, Okusaka T, Furuse J. A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2018 Jun;81(6):1017-1023. doi: 10.1007/s00280-018-3577-9. Epub 2018 Apr 9.
citation: Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. doi: 10.1159/000091635.