Paclitaxel i.v. Plus Cisplatin i.p for NACT in Patients With Advanced Ovarian Cancer

NCT04885270 | Unknown Phase 3

• 1 other identifier: WestChinaSUH2020076
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To test the effect of intravenous paclitaxel plus intraperitoneal cisplatin for neo-adjuvant chemotherapy in patients with advanced ovarian cancer, the investigators conducted a phase III single arm clinical trial. Included patients will receive interval debulking surgery after 2-6 cycles neoadjuvant chemotherapy based on the clinical judgment of the gynecologic oncologist. Six cycles of chemotherapy will conducted after surgery. And the neoadjuvant chemotherapy is as follows: paclitaxel 135 mg/m2 i.v. and cisplatin 75 mg/m2 i.p. on day 1. The primary end point is optimal debulking rates. the investigators also will evaluate effect on parameters of volume of ascites, tumor size, duration of surgery, hemorrhage, hospitalizations and postoperative complication etc. After comparing with data published online, the investigators will try to find out if paclitaxel i.v. plus cisplatin i.p. is a superior neoadjuvant chemotherapy for advanced ovarian carcinoma.

Conditions

Epithelial Carcinoma, Ovarian; Neoadjuvant Chemotherapy

Keywords

intraperitoneal chemotherapy; neoadjuvant chemotherapy; Epithelial ovarian cancer

Outcome Measures

Primary Outcomes (2)

• Optimal debulking rates

  Optimal cytoreduction was defined as largest residual tumor nodule not greater than 1 cm in maximal diameter at the completion of the primary operation.

  up to 18 weeks

• PFS

  Progression free survival

  Progression free survival (PFS) will be measured from the date enrollment to the first documented date of progression, or death, whichever occurs first, assessed up to 36 months.

Secondary Outcomes (1)

• OS

  Overall survival (OS) will be measured from the date of enrollment to the date of death, whatever the cause, assessed up to 36 months.

Study Arms (1)

Arm i.p

EXPERIMENTAL

paclitaxel i.v. and cisplatin i.p.

Drug: cisplatin i.p.

Interventions

cisplatin i.p. DRUG

paclitaxel 135 mg/m2 i.v. and cisplatin 75 mg/m2 i.p. on day 1

Also known as: intraperitoneal cisplatin

Arm i.p

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preferentially biopsy proven Stage IIIc or IV epithelial ovarian carcinoma, or peritoneal or fallopian tube carcinoma (the presence of metastases outside the pelvis measuring at least 2 cm in diameter (as noted during diagnostic laparoscopy or laparotomy or on computed tomography \[CT\]),with a low likelihood of achieving cytoreduction to, 1 cm (ideally to no visible disease). Or women who have a high perioperative risk profile.
• Fine needle aspiration (FNA) showing an adenocarcinoma and cytopathology from ascites or pleural effusion is acceptable under the following conditions:
• the patient has a pelvic (ovarian) mass, AND omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymphnode metastasis irrespective of size or stage IV AND serum CA125/CEA ratio \> 25. If the serum CA125/CEA ratio is \< 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) should be negative for the presence of a primary tumor (\< 6 weeks before randomization), and normal mammography (\< 6 weeks).
• WHO performance status of 0, 1, or 2.
• No other serious disabling diseases contraindicating for cytoreductive surgery or platin based chemotherapy.
• No other prior primary malignancies, except for carcinoma in situ of the cervix and basal carcinoma of the skin.
• No clinical evidence of brain or leptomeningeal metastases.
• Adequate hematological, renal and hepatic function to permit platin-paclitaxel based chemotherapy: WBC \> 3.0 x 109/L, N \>1.5 x 109/L, platelets \> 100 x 109/L, serum creatinine \< 1.25 x upper normal range, serum bilirubin \< 1.25 x upper normal range.
• Absence of any psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
• Before patient registration/randomization, informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.

You may not qualify if:

• serious disabling diseases that would contraindicate primary cytoreductive surgery or platinumbased chemotherapy
• mucinous or borderline histology, extensive intra-abdominal adhesions, bowel obstruction or unresolved\>grade 2 peripheral neuropathy.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (12)

• Rose PG, Nerenstone S, Brady MF, Clarke-Pearson D, Olt G, Rubin SC, Moore DH, Small JM; Gynecologic Oncology Group. Secondary surgical cytoreduction for advanced ovarian carcinoma. N Engl J Med. 2004 Dec 9;351(24):2489-97. doi: 10.1056/NEJMoa041125.

  PMID: 15590951 BACKGROUND

• Kehoe S, Hook J, Nankivell M, Jayson GC, Kitchener H, Lopes T, Luesley D, Perren T, Bannoo S, Mascarenhas M, Dobbs S, Essapen S, Twigg J, Herod J, McCluggage G, Parmar M, Swart AM. Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial. Lancet. 2015 Jul 18;386(9990):249-57. doi: 10.1016/S0140-6736(14)62223-6. Epub 2015 May 19.

  PMID: 26002111 BACKGROUND

• Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

  PMID: 20818904 BACKGROUND

• Wright AA, Bohlke K, Armstrong DK, Bookman MA, Cliby WA, Coleman RL, Dizon DS, Kash JJ, Meyer LA, Moore KN, Olawaiye AB, Oldham J, Salani R, Sparacio D, Tew WP, Vergote I, Edelson MI. Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Oct 1;34(28):3460-73. doi: 10.1200/JCO.2016.68.6907. Epub 2016 Aug 8.

  PMID: 27502591 BACKGROUND

• Lopez JA, Krikorian JG, Reich SD, Smyth RD, Lee FH, Issell BF. Clinical pharmacology of intraperitoneal cisplatin. Gynecol Oncol. 1985 Jan;20(1):1-9. doi: 10.1016/0090-8258(85)90118-0.

  PMID: 4038390 BACKGROUND

• Dedrick RL, Myers CE, Bungay PM, DeVita VT Jr. Pharmacokinetic rationale for peritoneal drug administration in the treatment of ovarian cancer. Cancer Treat Rep. 1978 Jan;62(1):1-11.

  PMID: 626987 BACKGROUND

• Tummala MK, Alagarsamy S, McGuire WP. Intraperitoneal chemotherapy: standard of care for patients with minimal residual stage III ovarian cancer? Expert Rev Anticancer Ther. 2008 Jul;8(7):1135-47. doi: 10.1586/14737140.8.7.1135.

  PMID: 18588458 BACKGROUND

• Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.

  PMID: 8960474 BACKGROUND

• Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.

  PMID: 16394300 BACKGROUND

• Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Feb 15;19(4):1001-7. doi: 10.1200/JCO.2001.19.4.1001.

  PMID: 11181662 BACKGROUND

• Tewari D, Java JJ, Salani R, Armstrong DK, Markman M, Herzog T, Monk BJ, Chan JK. Long-term survival advantage and prognostic factors associated with intraperitoneal chemotherapy treatment in advanced ovarian cancer: a gynecologic oncology group study. J Clin Oncol. 2015 May 1;33(13):1460-6. doi: 10.1200/JCO.2014.55.9898. Epub 2015 Mar 23.

  PMID: 25800756 BACKGROUND

• Provencher DM, Gallagher CJ, Parulekar WR, Ledermann JA, Armstrong DK, Brundage M, Gourley C, Romero I, Gonzalez-Martin A, Feeney M, Bessette P, Hall M, Weberpals JI, Hall G, Lau SK, Gauthier P, Fung-Kee-Fung M, Eisenhauer EA, Winch C, Tu D, MacKay HJ. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer. Ann Oncol. 2018 Feb 1;29(2):431-438. doi: 10.1093/annonc/mdx754.

  PMID: 29186319 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 13, 2021
• Study Start: August 4, 2021
• Primary Completion: May 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)