Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00770874
Other study ID # 10020380
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2008
Est. completion date April 2016

Study information

Verified date March 2019
Source Taiho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Japan Cancer Institute Hospital Ariake, Koto-ku Tokyo
Japan Yanagawa Hospital Chikushimachi, Yanagawa Fukuoka
Korea, Republic of Konkuk University Medical Center Hwayang-dong, Gwangjin-gu Seoul
Taiwan Chang Gung Medical Foundation- Linkou Fu-Hsing Saint Kuei Shan Hsiang TaoYuan Hsien

Sponsors (1)

Lead Sponsor Collaborator
Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Progression Free Survival, Safety Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. 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
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A