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

Taiho Pharma

Status and phase

Completed

Phase 3

Conditions

Cervical Cancer

Treatments

Drug: Cisplatin (arm B)

Drug: S-1 + Cisplatin (arm A)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00770874

10020380

Details and patient eligibility

About

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.

Full 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.

Enrollment

375 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.