- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661696
Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in Ovarian Cancer.
Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer: a Multicenter, Open, Phase 2 Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: yangchun Sun
- Phone Number: 13661355755
- Email: yfc1303700@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- yangchun Su
- Phone Number: 13661355755
- Email: yfc1303700@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age :18-75years old;
- Histopathological confirmed epithelial ovarian cancer/fallopian tube/peritoneal cancer; Mucinous adenocarcinoma and low-grade serous carcinoma are excluded;
- Recurrence more than 6 months after the last treatment with taxanes and platinum; Relapse ≤ 3 times; Recovered from the toxicity of the previous chemotherapy to ≤ 1 (hair loss ≤ 2);
Relapse confirmed by imaging and CA125:
- Clinically evaluable recurrent lesions. According to the RECIST 1.1 , there is at least one measurable lesion as the target lesion. If the target lesion is a lymph node, the shorter diameter is required to be greater than 1.5 cm, and the target lesion has not received radiotherapy;
- No clinically evaluable lesions:
i. Adenocarcinoma cells are confirmed by cytology in the pleural and ascites; ii. Imaging considers that there is tumor recurrence, but the lesions do not meet the measurable standard. They are all small lesions (longest diameter <10 mm or pathological lymph node short diameter ≥10 mm to <15 mm). CA125 ≥ normal upper limit (ULN) 2 times, and CA125 is still showing an upward trend after rechecking after 1 week; c) Patients with recurrence can receive a second cytoreductive surgery. Postoperative R0 resection or residual tumor can be included in the group.
- ECOG score 0-1;
- Expected survival time ≥ 3 months;
- Laboratory tests: absolute neutrophil count (ANC): ≥1.5×10^9/L; platelets (PLT):≥100×10^9/L;hemoglobin (Hb): ≥90g/L (blood transfusions are allowed to meet or maintain the targets);
- Liver and renal function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or <ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times or ≤ ULN 2.5 times when the patients have Gilbert's syndrome; Serum creatinine ≤ ULN 1.5 times or Calculated creatinine clearance ≥ 50 mL/min;
- Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.
- Signed the informed consent.
Exclusion Criteria:
- Patients who had previously received paclitaxel (albumin-bound);
- Patients who have received abdominal or pelvic radiotherapy;
- Patients with central nervous system disease or brain metastases;
- Other malignancies have occurred within the last 5 years, except for cured cervical carcinoma in situ, cutaneous squamous cell carcinoma or controlled basal cell carcinoma of the skin;
- Prior Grade ≥ 2 sensory or motor neuropathy;
- Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
- Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
- Receive other anti-tumor drugs or participate in other anti-cancer treatment clinical studies within 4 weeks of the first chemotherapy administration;
- Severe infections occurred within 4 weeks before treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
- Human immunodeficiency virus (HIV) positive;
- Hepatitis B surface antigen (HBsAg) positive. For patients with previous HBV infection or HBV infection cured (the HBsAg is negative, but the total hepatitis B virus core antibody [HBcAb] is positive), if HBV DNA is negative or Undetectable, they can participate in this research;
- Hepatitis C virus (HCV) antibody positive; Or human immunodeficiency virus and HCV RNA test both positive;
- Researchers think it is not suitable for enrolling.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-arm
Paclitaxel (albumin-bound) 130 mg/m2, i.v., d1, 8; Carboplatin AUC 5, i.v.
d1; repeat every 21days, 6 cycles.
|
The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed.
Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival(PFS)
Time Frame: up to 36 months
|
From date of randomization until the date of first documented progression or died
|
up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate(ORR)
Time Frame: up to 36 months
|
The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.
|
up to 36 months
|
Overall survival(OS)
Time Frame: up to 36 months
|
From date of randomization until the date of death from any cause
|
up to 36 months
|
disease control rate(DCR)
Time Frame: up to 36 months
|
including CR, PR, SD
|
up to 36 months
|
hematological toxicity and non-hematological toxicity
Time Frame: up to 36 months
|
including hematological toxicity and non-hematological toxicity
|
up to 36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Lingying Wu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 19/339-2123
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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