Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma

NCT00226915 | Completed Phase 3 DMC

• 2 other identifiers: JGOG3016C000000183 (by UMIN)
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Keywords

ovarian neoplasms; randomized controlled trial; paclitaxel; carboplatin

Outcome Measures

Primary Outcomes (1)

• Progression Free Suvaival

  From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence. Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital

  During the protocol treatment then 18 months from the last day of the protocol treatment

Secondary Outcomes (3)

• Overall Survival

  During the protocol treatment then 18 months from the last day of the protocol treatment

• QOL

  During the protocol treatment then 18 months

• Adverse Event

  During the protocol treatment then 18 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

Drug: Paclitaxel+Carboplatin

2

EXPERIMENTAL

Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles

Drug: Paclitaxel+Carboplatin

Interventions

Paclitaxel+Carboplatin DRUG

Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

1

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
• No prior chemotherapy
• Age: 20 and more
• Performance status: ECOG 0-3
• \) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL
• Written informed consent

You may not qualify if:

• Patients with ovarian borderline tumor
• Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy
• Patients with active infection or uncontrolled diabetes
• Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
• Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)

Sponsors & Collaborators

• Japanese Gynecologic Oncology Group: lead

Study Sites (1)

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Related Publications (29)

• McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996 Jan 4;334(1):1-6. doi: 10.1056/NEJM199601043340101.

  PMID: 7494563 BACKGROUND

• Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. doi: 10.1200/JCO.2003.09.081. Epub 2003 Feb 13.

  PMID: 12668651 BACKGROUND

• Heintz AP, Odicino F, Maisonneuve P, Beller U, Benedet JL, Creasman WT, Ngan HY, Sideri M, Pecorelli S. Carcinoma of the ovary. J Epidemiol Biostat. 2001;6(1):107-38. No abstract available.

  PMID: 11385772 BACKGROUND

• Strnad CM, Grosh WW, Baxter J, Burnett LS, Jones HW 3rd, Greco FA, Hainsworth JD. Peritoneal carcinomatosis of unknown primary site in women. A distinctive subset of adenocarcinoma. Ann Intern Med. 1989 Aug 1;111(3):213-7. doi: 10.7326/0003-4819-111-3-213.

  PMID: 2502058 BACKGROUND

• Feuer GA, Shevchuk M, Calanog A. Normal-sized ovary carcinoma syndrome. Obstet Gynecol. 1989 May;73(5 Pt 1):786-92.

  PMID: 2704507 BACKGROUND

• Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.

  PMID: 10793106 BACKGROUND

• Muggia FM, Braly PS, Brady MF, Sutton G, Niemann TH, Lentz SL, Alvarez RD, Kucera PR, Small JM. Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: a gynecologic oncology group study. J Clin Oncol. 2000 Jan;18(1):106-15. doi: 10.1200/JCO.2000.18.1.106.

  PMID: 10623700 BACKGROUND

• International Collaborative Ovarian Neoplasm Group. Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial. Lancet. 2002 Aug 17;360(9332):505-15. doi: 10.1016/S0140-6736(02)09738-6.

  PMID: 12241653 BACKGROUND

• Alberts DS, Green S, Hannigan EV, O'Toole R, Stock-Novack D, Anderson P, Surwit EA, Malvlya VK, Nahhas WA, Jolles CJ. Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide: final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer. J Clin Oncol. 1992 May;10(5):706-17. doi: 10.1200/JCO.1992.10.5.706.

  PMID: 1569443 BACKGROUND

• Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, Gianni L, Myles J, van der Burg ME, Kerr I, Vermorken JB, Buser K, Colombo N, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol. 1994 Dec;12(12):2654-66. doi: 10.1200/JCO.1994.12.12.2654.

  PMID: 7989941 BACKGROUND

• Bois AD, Lueck HJ, Meier W, Moebus V, Costa SD, Bauknecht T, Richter B, Warm M, Schroeder W, Olbricht S, Nitz U, Jackisch C. Cisplatin/Paclitaxel Vs Carboplatin/Paclitaxel in Ovarian Cancer: Update of an Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group Trial. American Society of Clinical Oncology 18:356a(Abstract 1374), 1999.

  BACKGROUND

• Ozols R, Bundy B, Fowler J, Clarke-Pearson D, Mannel R, Hartenbach E , Baergen R. Randomized Phase III Study of Cisplatin (CIS)/Paclitaxel (PAC) Versus Carboplatin (CARBO)/PAC in Optimal Stage III Epithelial Ovarian Cancer (OC): A Gynecologic Oncology Group Trial (GOG 158). American Society of Clinical Oncology 18:356a(Abstract.1373), 1999.

  BACKGROUND

• Bertelsen K, Jakobsen A, Stroyer J, Nielsen K, Sandberg E, Andersen JE, Ahrons S, Nyland M, Hjortkjaer Pedersen P, Larsen G, et al. A prospective randomized comparison of 6 and 12 cycles of cyclophosphamide, adriamycin, and cisplatin in advanced epithelial ovarian cancer: a Danish Ovarian Study Group trial (DACOVA). Gynecol Oncol. 1993 Apr;49(1):30-6. doi: 10.1006/gyno.1993.1081.

  PMID: 8482557 BACKGROUND

• Hakes TB, Chalas E, Hoskins WJ, Jones WB, Markman M, Rubin SC, Chapman D, Almadrones L, Lewis JL Jr. Randomized prospective trial of 5 versus 10 cycles of cyclophosphamide, doxorubicin, and cisplatin in advanced ovarian carcinoma. Gynecol Oncol. 1992 Jun;45(3):284-9. doi: 10.1016/0090-8258(92)90305-3.

  PMID: 1612505 BACKGROUND

• Planner RS, Allen DG, Brand AH, Grant PT, Toner GC, Sykes PH. Paclitaxel (Taxol) as salvage therapy for relapsed ovarian cancer. Aust N Z J Obstet Gynaecol. 1996 May;36(2):168-70. doi: 10.1111/j.1479-828x.1996.tb03278.x.

  PMID: 8798307 BACKGROUND

• Hudis C. New approaches to adjuvant chemotherapy for breast cancer. Pharmacotherapy. 1996 May-Jun;16(3 Pt 2):88S-93S.

  PMID: 8726587 BACKGROUND

• Tan G, Heqing L, Jiangbo C, Ming J, Yanhong M, Xianghe L, Hong S, Li G. Apoptosis induced by low-dose paclitaxel is associated with p53 upregulation in nasopharyngeal carcinoma cells. Int J Cancer. 2002 Jan 10;97(2):168-72. doi: 10.1002/ijc.1591.

  PMID: 11774260 BACKGROUND

• Torres K, Horwitz SB. Mechanisms of Taxol-induced cell death are concentration dependent. Cancer Res. 1998 Aug 15;58(16):3620-6.

  PMID: 9721870 BACKGROUND

• Fennelly D, Aghajanian C, Shapiro F, O'Flaherty C, McKenzie M, O'Connor C, Tong W, Norton L, Spriggs D. Phase I and pharmacologic study of paclitaxel administered weekly in patients with relapsed ovarian cancer. J Clin Oncol. 1997 Jan;15(1):187-92. doi: 10.1200/JCO.1997.15.1.187.

  PMID: 8996141 BACKGROUND

• Bremer K. Weekly Paclitaxel/Carboplatin as First-Line Chemotherapy in Advanced Ovarian Cancer. American Society of Clinical Oncology 18:367a(Abstract. 1419), 1999.

  BACKGROUND

• Katsumata N, Watanabe T, Mukai H, Kasamatsu T, Tsunematsu R, Yamada T, Ohmi K. A Phase II Trial of Weekly Paclitaxel/Carboplatin (TJ) as Salvage Chemotherapy in Patients with Relapsed Ovarian Cancer. American Society of Clinical Oncology 20:217a(Abstract. 865), 2001.

  BACKGROUND

• Belani C, Barstis J, Perry M, Larocca R, Nattam S, Clark R, Rinaldi D, Mills G. Phase II Multicenter Randomized Trial of Weekly Paclitaxel (P) Administered in Combination with Carboplatin (C) Followed by Maintenance P Vs. Observation for Patients (Pts.) with Advanced & Metastatic Non-Small Cell Lung Cancer (NSCLC). American Society of Clinical Oncology 20:323a(Abstract. 1287), 2001.

  BACKGROUND

• Yasuda M, Kimura E, Ochiai K, Tada S, Udagawa Y, Aoki D, Nozawa S, Kikuchi Y, Kita T, Nishida M, Tsunoda H. [Dose finding study of paclitaxel and carboplatin for ovarian cancer (JKTB)]. Gan To Kagaku Ryoho. 2001 Apr;28(4):493-8. Japanese.

  PMID: 11329783 BACKGROUND

• Onnis A, Marchetti M, Padovan P, Castellan L. Neoadjuvant chemotherapy in advanced ovarian cancer. Eur J Gynaecol Oncol. 1996;17(5):393-6.

  PMID: 8933839 BACKGROUND

• Aure JC, Hoeg K, Kolstad P. Clinical and histologic studies of ovarian carcinoma. Long-term follow-up of 990 cases. Obstet Gynecol. 1971 Jan;37(1):1-9. No abstract available.

  PMID: 4321469 BACKGROUND

• Bois A, Weber B, Pfisterer J, Goupil A, Wagner U, Barats J, Olbricht S, Mousseau M, Nitz U, Meden H. Epirubicin/Paclitaxel/Carboplatin (TEC) Vs. Paclitaxel/Carboplatin (TC) in First-Line Treatment of Ovarian Cancer FIGO Stages IIb-IV. Interim Results of an AGO-GINECO Intergroup Phase III Trial. American Society of Clinical Oncology 20:202a(Abstract.805), 2001.

  BACKGROUND

• Harano K, Terauchi F, Katsumata N, Takahashi F, Yasuda M, Takakura S, Takano M, Yamamoto Y, Sugiyama T. Quality-of-life outcomes from a randomized phase III trial of dose-dense weekly paclitaxel and carboplatin compared with conventional paclitaxel and carboplatin as a first-line treatment for stage II-IV ovarian cancer: Japanese Gynecologic Oncology Group Trial (JGOG3016). Ann Oncol. 2014 Jan;25(1):251-7. doi: 10.1093/annonc/mdt527.

  PMID: 24356636 DERIVED

• Katsumata N, Yasuda M, Isonishi S, Takahashi F, Michimae H, Kimura E, Aoki D, Jobo T, Kodama S, Terauchi F, Sugiyama T, Ochiai K; Japanese Gynecologic Oncology Group. Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. Lancet Oncol. 2013 Sep;14(10):1020-6. doi: 10.1016/S1470-2045(13)70363-2. Epub 2013 Aug 13.

  PMID: 23948349 DERIVED

• Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.

  PMID: 19767092 DERIVED

Related Links

• Please refer "ongoing studies" (in Japanese)

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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; Fallopian Tube Diseases

Study Officials

• Makoto Yasuda, M.D.

  The Jikei University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: April 1, 2003
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

JP (1)