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

NCT04611724 | Unknown Phase 2 FDA Drug

• 1 other identifier: ULTIMA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Urachal Cancer

Keywords

Urachal Cancer; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate

  up to 2 years

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  every 2 weeks up to 30 weeks.

• Progression-free survival (PFS)

  up to 2years.

• Overall survival (OS),

  up to 5 years.

• Incidence of febrile neutropenia

  After study completion (an average of 2 year)

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

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

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

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

FOLFIRINOX

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Asan Medical Center: lead
• Green Cross Corporation: collaborator
• Boryung Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 29633005 BACKGROUND

• 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.

  PMID: 16601395 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Urachal cancer

Interventions

folfirinox

Study Officials

• Jae -Lyun Lee, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae -Lyun Lee, Professor

CONTACT

82 2 3010 5977; jaelyun@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: September 30, 2024
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)