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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    35
  • sponsor
    Asan Medical Center
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Updated on 26 January 2021
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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.

Details
Condition Urachal Cancer
Treatment FOLFIRINOX
Clinical Study IdentifierNCT04611724
SponsorAsan Medical Center
Last Modified on26 January 2021

Eligibility

 Yes No Not Sure

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 )
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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