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

Phase 2

Recruiting

• Conditions: Urachal Cancer
• Interventions: Drug: FOLFIRINOX

• Registration Number: NCT04611724
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02
• Study Start: 2020-12-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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.

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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 )

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRINOX	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

Primary Outcome Measures

Name	Time	Method
Objective response rate	up to 2 years	Objective response rate

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	every 2 weeks up to 30 weeks.	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Progression-free survival (PFS)	up to 2years.	Progression-free survival (PFS)
Overall survival (OS),	up to 5 years.	Overall survival (OS),
Incidence of febrile neutropenia	After study completion (an average of 2 year)	Incidence of febrile neutropenia

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of