Status:
COMPLETED
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
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 s...
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 singl...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00770874
Start Date
September 1 2008
End Date
April 1 2016
Last Update
June 21 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Yanagawa Hospital
Chikushimachi, Yanagawa, Fukuoka, Japan, 832-0077
2
Cancer Institute Hospital
Ariake, Koto-ku, Tokyo, Japan, 135-8550
3
Konkuk University Medical Center
Hwayang-dong, Gwangjin-gu, Seoul, South Korea, 143-729
4
Chang Gung Medical Foundation- Linkou
Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, Taiwan, 33305