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

NCT00770874 | Completed Phase 3 Results

• 1 other identifier: 10020380
• Study Type: interventional
• Target: 375
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months

Secondary Outcomes (1)

• Progression Free Survival, Safety

  About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment

Study Arms (2)

1

EXPERIMENTAL

S-1 + Cisplatin (arm A)

Drug: S-1 + Cisplatin (arm A)

2

ACTIVE COMPARATOR

Cisplatin (arm B)

Drug: Cisplatin (arm B)

Interventions

S-1 + Cisplatin (arm A) DRUG

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.

1

Cisplatin (arm B) DRUG

Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.

2

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Chemotherapy: 21 days
• Radiotherapy: 21 days\*
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Yanagawa Hospital

Chikushimachi, Yanagawa, Fukuoka, 832-0077, Japan

Location

Cancer Institute Hospital

Ariake, Koto-ku, Tokyo, 135-8550, Japan

Location

Konkuk University Medical Center

Hwayang-dong, Gwangjin-gu, Seoul, 143-729, South Korea

Location

Chang Gung Medical Foundation- Linkou

Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, 33305, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

S 1 (combination); Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Taiho Pharmaceutical Co., Ltd.
• Organization: Clinical Trial Registration Contact

toiawase@taiho.co.jp

Study Officials

• Ken Takizawa, MD

  Cancer Institute Hospital

  STUDY CHAIR

• Toshiharu Kamura, MD

  Yanagawa Hospital

  STUDY CHAIR

• Ting-Chang Chang, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

• Soon-Beom Kang, MD

  Konkuk University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-03

Locations

KR (1); TW (1); JP (2)