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

NCT ID: NCT00226915

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 637 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2012-06-30

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.

Detailed Description

This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms.

Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles.

PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Paclitaxel+Carboplatin

Intervention Type: DRUG

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

2

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

Group Type: EXPERIMENTAL

Paclitaxel+Carboplatin

Intervention Type: DRUG

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

Interventions

Paclitaxel+Carboplatin

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

Intervention Type: DRUG

Paclitaxel+Carboplatin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 1) 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Japanese Gynecologic Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Makoto Yasuda, M.D.

Role: STUDY_CHAIR

The Jikei University School of Medicine

Locations

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 7494563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12668651 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11385772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2502058 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2704507 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10793106 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10623700 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12241653 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1569443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7989941 (View on PubMed)

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8482557 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1612505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8798307 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 8726587 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11774260 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 9721870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8996141 (View on PubMed)

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

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11329783 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 8933839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4321469 (View on PubMed)

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 24356636 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23948349 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19767092 (View on PubMed)

Related Links

http://www.jgog.gr.jp/

Please refer "ongoing studies" (in Japanese)

Other Identifiers

C000000183 (by UMIN)

Identifier Type: -

Identifier Source: secondary_id

JGOG3016

Identifier Type: -

Identifier Source: org_study_id