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Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer (OC-01)

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ClinicalTrials.gov Identifier: NCT03818282
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Brief Summary:
Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Paclitaxel for injection (albumin-bound) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Paclitaxel for injection (albumin-bound) Drug: Paclitaxel for injection (albumin-bound)
Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.




Primary Outcome Measures :
  1. Progression free Survival [ Time Frame: 2 year ]
    PFS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 to 75 years;
  • Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
  • Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
  • Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
  • ECOG performance status of 0-2;
  • Expected survival ≥ 3 months;
  • Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
  • Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
  • 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.

Exclusion Criteria:

  • Ovarian low-grade malignant tumor patients;
  • 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 cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
  • 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.;
  • Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
  • Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
  • Patients not suitable for participation in this study judged by investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818282


Contacts
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Contact: Ding Ma, M.D. 02783663351 dma@tjh.tjmu.edu.cn
Contact: Danhui Weng, M.D. 02783663351 weng.dh@gmail.com

Sponsors and Collaborators
Huazhong University of Science and Technology

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Responsible Party: Ding Ma, Director, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03818282     History of Changes
Other Study ID Numbers: 2019-GYN/OC-01
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action