Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

Официальное название

Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

Обзор

The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.

Подробное описание

One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.

Вмешательства

• Препарат nab-paclitaxel combined with carboplatin
  Nab-Paclitaxel/carboplatin q3weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC（area under the curve） 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC（area under the curve）2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles Paclitaxel 175 mg/m² IV followed by carboplatin AUC（area under the curve）5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60

Первичные конечные точки

• Progression Free Survival [Срок оценки: 20 months]

Вторичные конечные точки (3)

• Objective Remission Rate [Срок оценки: 12 months]
• Survival [Срок оценки: 3 years, 5 years]
• Adverse events [Срок оценки: 3 years, 5 years]

Критерии участия

Критерии включения

• Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO（International Federation of Gynecology and Obstetrics）stage
• Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
• Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
• Written informed consent
• Expected survival ≥6 months
• The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
• Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.

Критерии исключения

• Patients with low malignant potential ovarian tumors;
• Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
• Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
• Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
• Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
• Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA（New York Heart Association） criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicated by color Doppler ultrasonography;
• Uncontrolled systemic infection requiring anti-infective treatment;
• Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
• Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
• Pregnant or lactating women;
• Those who were considered unsuitable for inclusion by the researchers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Китай · 11 центров

• Sun Yat-Sen University Cancer Hospital — Гуанчжоу
• Qilu Hospital of Shandong University — Ji'nan
• Yaxia Chen — Ханчжоу
• Sir Run Run Hospital — Ханчжоу
• The First Affiliated Hospital of Medical College of Zhejiang University — Ханчжоу
• The Second Affiliated Hospital of Medical College of Zhejiang University — Ханчжоу
• Zhejiang Cancer Hospital — Ханчжоу
• Ningbo women's and children's Hospital — Ningbo
• … и ещё 3 центра

Публикации

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• Zheng L, Cui C, Shi O, Lu X, Li YK, Wang W, Li Y, Wang Q. Incidence and mortality of ovarian cancer at the global, regional, and national levels, 1990-2017. Gynecol Oncol. 2020 Oct;159(1):239-247. doi: 10.1016/j.ygyno.2020.07.008. Epub 2020 Jul 18. PMID 32690392
• Zeighami S, Soltani M, Khajeh F, Ariafar A, Naghdi-Sedeh N. Testicular papillary serous carcinoma of ovarian type, a rare case report, however an important timely diagnostic issue. Urol Case Rep. 2020 Jun 16;33:101301. doi: 10.1016/j.eucr.2020.101301. eCollection 2020 Nov. PMID 33102004
• Dueckelmann AM, Fink D, Harter P, Heinzelmann V, Marth C, Mueller M, Reinthaller A, Tamussino K, Wimberger P, Sehouli J. The use of PIPAC (pressurized intraperitoneal aerosol chemotherapy) in gynecological oncology: a statement by the "Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)", the Swiss and Austrian AGO, and the North-Eastern German Society of Gynaeco PMID 29356953
• Perez-Fidalgo JA, Grau F, Farinas L, Oaknin A. Systemic treatment of newly diagnosed advanced epithelial ovarian cancer: From chemotherapy to precision medicine. Crit Rev Oncol Hematol. 2021 Feb;158:103209. doi: 10.1016/j.critrevonc.2020.103209. Epub 2020 Dec 31. PMID 33388455
• Huang CY, Cheng M, Lee NR, Huang HY, Lee WL, Chang WH, Wang PH. Comparing Paclitaxel-Carboplatin with Paclitaxel-Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer. Int J Environ Res Public Health. 2020 Mar 26;17(7):2213. doi: 10.3390/ijerph17072213. PMID 32224896
• Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. PMID 12860964
• Ratanajarusiri T, Sriuranpong V, Sitthideatphaiboon P, Poovoravan N, Vinayanuwat C, Parinyanitikul N, Angspatt P, Thawinwisan W, Tanasanvimon S. A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes. Chemotherapy. 2017;62(2):134-139. doi: 10.1159/000450748. Epub 2016 Dec 20. PMID 27997900

Идентификаторы

NCT: NCT05737303 · IRB-20230058-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗