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

Fallopian Tube Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226915
• Other study ID #: JGOG3016
• Secondary ID: C000000183 (by U
• Status: Completed
• Phase: Phase 3
• Start date: April 2003
• Est. completion date: June 2012

Study information

• Verified date: February 2020
• Source: Japanese Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Primary Peritoneal Cancer

Intervention

Drug:
• Paclitaxel+Carboplatin
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
• Paclitaxel+Carboplatin
Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japanese Gynecologic Oncology Group

Country where clinical trial is conducted

Japan, 

References & Publications (26)

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Bertelsen K, Jakobsen A, Strøyer 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. — View Citation

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.

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.

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

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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. — View Citation

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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. — View Citation

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.

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. — View Citation

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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.

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. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	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
Secondary	QOL	QOL assessed by FACT-Taxane(Version 4A)	During the protocol treatment then 18 months
Secondary	Adverse Event	Adverse Event assessed by CTC(Version 2.0 Japanese version)	During the protocol treatment then 18 months

External Links

•   Please refer "ongoing studies" (in Japanese)