Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00770874
First received: October 9, 2008
Last updated: February 18, 2014
Last verified: February 2014
  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 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: Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

Resource links provided by NLM:


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: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
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: NCT00770874

Locations
Japan
Kurume University Hospital
Asahi-machi, Kurume-shi, Fukuoka, Japan, 830-0011
Cancer Institute Hospital
Ariake, Koto-ku, Tokyo, Japan, 135-8550
Korea, Republic of
Konkuk University Medical Center
Hwayang-dong, Gwangjin-gu, Seoul, Korea, Republic of, 143-729
Taiwan
Chang Gung Medical Foundation- Linkou
Fu-Hsing St. Kuei Shan Hsiang, TaoYuan Hsien, Taiwan, 33305
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 Konkuk University Medical Center
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00770874     History of Changes
Other Study ID Numbers: 10020380
Study First Received: October 9, 2008
Last Updated: February 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 20, 2014