Trial of Tri-Weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma - Full Text View

Sponsored by:	Japanese Gynecologic Oncology Group
Information provided by:	Japanese Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00226915

Purpose

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.

Condition	Intervention	Phase
Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer	Drug: Paclitaxel+Carboplatin	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Japanese Gynecologic Oncology Group:

Primary Outcome Measures:

Progression Free Suvaival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: During the protocol treatment then 18 months from the last day of the protocol treatment ] [ Designated as safety issue: No ]
Adverse Event [ Time Frame: During the protocol treatment then 18 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: During the protocol treatment then 18 months ] [ Designated as safety issue: No ]

Enrollment:	637
Study Start Date:	April 2003
Study Completion Date:	November 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Drug: Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles	Drug: Paclitaxel+Carboplatin Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
2: Experimental Drug: Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles	Drug: Paclitaxel+Carboplatin Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226915

Locations

Japan, Tokyo
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan

Sponsors and Collaborators

Japanese Gynecologic Oncology Group

Investigators

Study Chair:

Makoto Yasuda, M.D.

The Jikei University School of Medicine

More Information

Additional Information:

Please refer "ongoing studies" (in Japanese) This link exits the ClinicalTrials.gov site

Publications:

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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.

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.

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. Erratum in: Lancet. 2003 Feb 22;361(9358):706.

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. Erratum in: J Clin Oncol 1992 Sep;10(9):1505.

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.

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.

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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.

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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.

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.

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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.

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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.

Responsible Party:	Japanese Gynecologic Oncology Group ( Kiichirou Noda / President )
Study ID Numbers:	JGOG3016, C000000183 (by UMIN)
Study First Received:	September 23, 2005
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00226915 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japanese Gynecologic Oncology Group:

ovarian neoplasms
randomized controlled trial
paclitaxel
carboplatin

Study placed in the following topic categories:

Fallopian Tube Cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Ovarian Diseases
Ovarian Epithelial Cancer

Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Paclitaxel
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Ovarian Diseases
Pharmacologic Actions

Fallopian Tube Neoplasms
Adnexal Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009