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Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
This study is currently recruiting participants.
Verified by Taiho Pharmaceutical Co., Ltd., January 2009
First Received: October 9, 2008   Last Updated: January 19, 2009   History of Changes
Sponsored by: Taiho Pharmaceutical Co., Ltd.
Information provided by: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00770874
  Purpose

This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.


Condition Intervention Phase
Cervical Cancer
Drug: S-1 + Cisplatin (arm A)
Drug: Cisplatin (arm B)
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin S 1 (Combination)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase III Study of S-1 + Cisplatin Compared With Single-Agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival, Overall response rate, safety [ Time Frame: Once every 3 months (PFS), Once every 6 weeks (ORR), anytime (safety) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: September 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
S-1 + Cisplatin (arm A)
Drug: S-1 + Cisplatin (arm A)
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
2: Active Comparator
Cisplatin (arm B)
Drug: Cisplatin (arm B)
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.

Detailed Description:

Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.

  Eligibility

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

Inclusion Criteria:

  • Patients with histologically proven cervical carcinoma (All histological subtype will be included).
  • Patients who have stage IVB, recurrent or persistent disease.
  • Patients who are not amenable to curative treatment with surgery and/or radiotherapy.
  • Patients who have not received chemotherapy or chemoradiotherapy after diagnosis of recurrent, persistent, or stage IVB disease.
  • If the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment:

    1. Chemotherapy: 21 days
    2. Radiotherapy: 21 days*
    3. Chemoradiotherapy: 42 days*

If there have been residual disease in previously irradiated field and without disease progression since the (chemo) radiotherapy, 90 days must have elapsed after the last administration of irradiation.

  • Patients who have adequate hematologic, hepatic and renal functions as defined below:

    • Hemoglobin: ≥ 8.0 g/dL
    • Neutrophil count: ≥ 2,000/mm^3
    • Platelet count: ≥ 100,000/mm^3
    • Total serum bilirubin: ≤ 1.5 times the upper limits of normal (ULN)
    • AST (GOT), ALT (GPT): ≤ 2.5 times the ULN. If abnormal values are associated with hepatic metastasis: ≤ 5.0 times the ULN
    • Serum creatinine: ≤ ULN or creatinine clearance: ≥ 50 ml/min
  • Patients who have an ECOG performance status : 0-1.
  • Age: ≥ 20 years old.
  • Patients who can take pills orally.
  • Patients who signed the written consent form.

Exclusion Criteria:

  • Patients who have known hypersensitivity to 5-FU or Cisplatin.
  • Patients who are receiving concomitant treatment with drugs interacting with S-1.
  • Patients who are receiving concomitant treatment with drugs interacting with Cisplatin.
  • Patients who were administered other investigational products within 30 days before the initiation of study treatment.
  • Patients who were previously treated with S-1.
  • Patients who had received platinum-containing chemotherapy or chemoradiotherapy and whose disease progressed during the therapy.
  • Patients who suffer from active infection (e.g. fever ≥ 38°C).
  • Patients who have serious complications.
  • Patients with bleeding which requires hemostasis treatment.
  • Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.
  • Patients with uncontrolled pleural effusion and/or ascites requiring drainage at least twice a week.
  • Patients with symptomatic brain metastasis or history of brain metastasis.
  • Patients who have unmanageable bowel movement (ex. Watery stool, chronic constipation).
  • Patients with active double cancer.
  • Patients who are pregnant or lactating.
  • Patients who are considered to be inappropriate to the subject of this study by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770874

Contacts
Contact: Masahiro Takeuchi +81-3-5791-6400 ctcc@insti.kitasato-u.ac.jp

Locations
Japan, Tokyo
Cancer Institute Hospital Recruiting
3-10-6, Ariake, Koto-ku, Tokyo, Japan, 135-8550
Contact: Yasuo Hirai, MD     +81-3-3520-0111        
Principal Investigator: Yasuo Hirai, MD            
Korea, Republic of, Seoul
Seoul National University Hospital Recruiting
28 Yeongeon-dong, Jongno-gu, Seoul, Korea, Republic of, 110-744
Contact: Soon-Beom Kang, MD     +82-2-2072-2380        
Principal Investigator: Soon-Beom Kang, MD            
Taiwan, TaoYuan Hsien
Chang Gung Memorial Hospital Linkou Recruiting
5. Fu-Hsing St. Kuei Shan Hsiang, TaoYuan Hsien, Taiwan, 33305
Contact: Ting-Chang Chang, MD     +886-3-3281200        
Principal Investigator: Ting-Chang Chang, MD            
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Study Chair: Ken Takizawa, MD Cancer Institute Hospital
Study Chair: Toshiharu Kamura, MD Kurume University
Study Chair: Ting-Chang Chang, MD Chang Gung Memorial Hospital Linkou
Study Chair: Soon-Beom Kang, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers: 10020380
Study First Received: October 9, 2008
Last Updated: January 19, 2009
ClinicalTrials.gov Identifier: NCT00770874     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Radiation-Sensitizing Agents
Cisplatin
Recurrence
Carcinoma

Additional relevant MeSH terms:
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009