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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Japanese Gynecologic Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Japanese Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00226915
First received: September 23, 2005
Last updated: April 2, 2012
Last verified: April 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
Drug: Paclitaxel+Carboplatin
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
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:
Publications:
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.
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Japanese Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00226915     History of Changes
Other Study ID Numbers: JGOG3016, C000000183 (by UMIN)
Study First Received: September 23, 2005
Last Updated: April 2, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japanese Gynecologic Oncology Group:
ovarian neoplasms
randomized controlled trial
paclitaxel
carboplatin

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014