The goal of this clinical trial is to learn if albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) works to treat advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma (cohort 1), rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5) . It will also learn about the safety of Nab-TIP. The main questions it aims to answer are: Does Nab-TIP improve the objective response rate and prolong the survival of participants? What medical problems do participants have when receiving the regimen of Nab-TIP? Participants will: Receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first. Be performed imaging evaluation according to RECIST 1.1 every 6 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria
This study is a single-arm phase II study, which aimed to evaluate the efficacy and safety of albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) in the treatment of advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma (cohort 1), rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5). Primary objective of this study is to evaluate the objective response rate (ORR) of Nab-TIP in the treatment of multiple rare advanced tumors. Secondary objectives are to evaluate the imaging progression-free survival (PFS), overall survival (OS) and safety in the treatment of multiple rare advanced tumors with Nab-TIP. The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up). Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility. Treatment period: Patients received albumin paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, cisplatin 25mg d2-5, repeated every three weeks, with 6 cycles of chemotherapy. Follow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment. After the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal of informed consent, or investigator termination of the study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participant will receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first.
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR)
ORR was defined as the proportion of patients who achieved either a complete response (CR) or a partial response (PR) based on the investigator's assessment (RECIST v1.1) that was confirmed by a subsequent scan ≥4 weeks after initial CR/PR.
Time frame: 12 weeks
Progression-free survival(PFS)
PFS was defined as the time between the enrollment and either RECIST1.1-defined progressive disease or death due to any cause, whichever occurred first.
Time frame: 1 year
Overall survival (OS)
OS was defined as the time between the enrollment and death due to any cause.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.