Phase II study of Belotecan monotherapy in patients with recurrent or persistent cervical cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004484

Enrollment

Registered

2019-11-29

Start date

2020-09-17

Completion date

Unknown

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Belotecan 0.5mg/m2 IV on day 1-5, Every 3weeks, 6cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) over 19 years old 2) Recurrence after surgery or concurrent chemoradiotherapy for initial treatment as a persistent cervical cancer patient, 3) histologically squamous cell carcinoma 4) RECIST standard version 1.1 (standard for evaluation of response in solid cancer) Abnormally measurable lesions (one-dimensional measurable lesions) 5) Patients with normal haematological functions, kidney and liver functions, at least the following long-term functions shall be measured;The target shall measure the normal organs and marrow functions defined below within 7 days before starting the treatment. Defined organs Organ and bone marrow function was measured. Hemoglobin =10 g / dL Absolute neutrophil count (ANC)> = 1.5x10P9P / L Platelets = 100x 10P9P / L -AST / ALT = 3 x ULN, if transition to liver = 5 x ULN Creatinine = ULN or calculated CrCl = 50ml / min 6) Patients with an expected survival period of 3 months or more 7) ECOG 0-2

Exclusion criteria

Exclusion criteria: 1) Histologically neuroendocrine type 2) Two or more regimens previously with recurrent / persistent cervical cancer If you received chemotherapy 3) If you have previously received topoisomerase I inhibitor 4) When bilateral receipt is not resolved by ureteral stent or percutaneous drainage 5) In case of brain metastasis 6) Non-melanoma skin cancer is accompanied by cancer diseases 7) If you have been previously treated for invasive cancer (except Non-melanoma skin cancer) 8) received systemic chemotherapy or radiation therapy within 3 weeks prior to clinical trial administration Patients (excluding radiation therapy for palliative care purposes)

Design outcomes

Primary

Measure	Time frame
Analyze the complete response rate through CT or MRI or PET imaging tests	—

Secondary

Measure	Time frame
Progression-free survival : Analyze survival outcomes using the Kaplan-Meir method;Side-effect	—

Countries

Korea, Republic of

Contacts

Public ContactLee Beom

Gachon University Gil Medical Center

Outcome results