A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer

Urachal Cancer Clinical Trial

Official title:

A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611724
• Other study ID #: ULTIMA
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2020
• Source: Asan Medical Center
• Contact: Jae -Lyun Lee, Professor
• Phone: 82 2 3010 5977
• Email: jaelyun[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

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 )

Related Conditions & MeSH terms

• Urachal Cancer

Intervention

Drug:
• FOLFIRINOX
oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Boryung Pharmaceutical Co., Ltd, Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. — View 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-naïve 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate	up to 2 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	every 2 weeks up to 30 weeks.
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS)	up to 2years.
Secondary	Overall survival (OS),	Overall survival (OS),	up to 5 years.
Secondary	Incidence of febrile neutropenia	Incidence of febrile neutropenia	After study completion (an average of 2 year)

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