- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226915
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Tokyo
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Chuo-ku, Tokyo, Japan
- National Cancer Center Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Drug: Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
|
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
|
Experimental: 2
Drug: Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
|
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Suvaival
Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment
|
The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored. In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored. |
During the protocol treatment then 18 months from the last day of the protocol treatment
|
QOL
Time Frame: During the protocol treatment then 18 months
|
QOL assessed by FACT-Taxane(Version 4A)
|
During the protocol treatment then 18 months
|
Adverse Event
Time Frame: During the protocol treatment then 18 months
|
Adverse Event assessed by CTC(Version 2.0 Japanese version)
|
During the protocol treatment then 18 months
|
Collaborators and Investigators
Investigators
- Study Chair: Makoto Yasuda, M.D., The Jikei University School of Medicine
Publications and helpful links
General Publications
- 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. Erratum In: J Clin Oncol. 2003 Jun 1;21(11):2226.
- 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.
- 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. Erratum In: J Clin Oncol 1992 Sep;10(9):1505.
- 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.
- 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.
- Feuer GA, Shevchuk M, Calanog A. Normal-sized ovary carcinoma syndrome. Obstet Gynecol. 1989 May;73(5 Pt 1):786-92.
- 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.
- 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.
- 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. Erratum In: Lancet. 2003 Feb 22;361(9358):706.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hudis C. New approaches to adjuvant chemotherapy for breast cancer. Pharmacotherapy. 1996 May-Jun;16(3 Pt 2):88S-93S.
- 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.
- Torres K, Horwitz SB. Mechanisms of Taxol-induced cell death are concentration dependent. Cancer Res. 1998 Aug 15;58(16):3620-6.
- 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.
- Bremer K. Weekly Paclitaxel/Carboplatin as First-Line Chemotherapy in Advanced Ovarian Cancer. American Society of Clinical Oncology 18:367a(Abstract. 1419), 1999.
- 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.
- 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.
- 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.
- Onnis A, Marchetti M, Padovan P, Castellan L. Neoadjuvant chemotherapy in advanced ovarian cancer. Eur J Gynaecol Oncol. 1996;17(5):393-6.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- JGOG3016
- C000000183 (by UMIN)
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