Phase
Condition
Malignant Ascites
Fallopian Tube Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have stage III or IV ovarian epithelial cancer, fallopian tube cancer orprimary peritoneal cancer.
Definite histopathological diagnosis.
Failed with treatment for taxane/doxorubicin and platinum.
Must have measurable disease with at least 1 unidimensional measurable lesion base onRECIST1.1. When evaluating the efficacy of patients with CA125 level, CA125abnormalities caused by other reasons should be excluded. According to the GynecologicCancer Intergroup-GCIG standard, the baseline serum CA125 level of patients within 2weeks before treatment should be ≥2 upper limit of normal.
Age between 18-65(inclusive).
ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1.
To estimated life expectancy of at least 3 months.
Appropriate blood routine, liver and kidney function.
No allergic history of camptothecin.
Patients who are able to take strict contraceptive measures during the trial andwithin 4 months after the end of the trial.
The patients are able to swallow and maintain oral medication.
More than 4 weeks from the end of previous surgery, chemotherapy, radiotherapy (non-pelvic and peritoneal sites) and targeted therapy before the study and the bodyhad recovered (the treatment-related toxicity grade is no more than grade 1, exceptfor hair loss and pigmentation).
Patients voluntarily give written informed consent to participate in the study.
Exclusion
Exclusion Criteria:
The patients are treated with irinotecan or topotecan or with any topoisomerase Iinhibitor regimen prior to enrollment.
Patients who use other experimental drugs or conducted other clinical trials at thesame time within 30 days before participate in the study.
To received radiotherapy of pelvic cavity and abdomen.
Smoking more than 5 cigarettes per day in the past year.
Suspected or real alcohol dependence with an average alcohol intake of more than 2units per day for 3 months.
Active infection.
patients with the history of gastrointestinal surgery or that may change drugabsorption and activity in the body.
Serious cardiovascular disease, including Ⅱ magnitude abnormal cardiac function.
having a clear history of neuropathy or mental disorders (including epilepsy ordementia).
Human immunodeficiency virus(HIV) positive, untreated active hepatitis.
Suffering from other malignant tumors other than this diseases in 5 years, except forbasal cell carcinoma of skin, skin squamous cell carcinoma, primary cervical carcinomaand breast cancer without recurrence and metastasis after radical operation.
Brain metastasis.
Female with pregnant or lactating.
Patients who are considered unsuitable to participate in the study.
Study Design
Study Description
Connect with a study center
Beijing Tumor Hospital
Beijing, Beijing
ChinaActive - Recruiting
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