Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer (GEST)

This study has been completed.
Sponsor:
Collaborator:
TTY Biopharm
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00498225
First received: July 6, 2007
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine plus TS-1
Drug: TS-1
Drug: Gemcitabine
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: Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)

Resource links provided by NLM:


Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Over all survival(OS) [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival (PFS), response rate (RECIST, if measurable), incidence rate of adverse events, incidence rate of adverse drug reactions, QOL (EQ-5D) [ Time Frame: adverse events will be collected during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 834
Study Start Date: July 2007
Study Completion Date: June 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gemcitabine plus TS-1
Drug: Gemcitabine plus TS-1
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
Experimental: 2
TS-1
Drug: TS-1
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
Active Comparator: 3
Gemcitabine
Drug: Gemcitabine
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
  • Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer).Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration.
  • Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1).
  • Age: 20 years to 79 years.
  • ECOG Performance Status (PS) of 0 or 1.
  • Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.) White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL* *≤ 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.** **Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum creatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.
  • Able to take capsules orally.
  • No clinically abnormal ECG findings within 28 days (4 weeks)before registration.
  • Voluntarily signed the written consent form.

Exclusion Criteria:

  • Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
  • Watery diarrhoea.
  • Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral hepatitis.
  • Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
  • Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
  • Metastasis in the CNS.
  • Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
  • Patients under treatment with flucytosine, phenytoin or warfarin potassium.
  • Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
  • Severe mental disorder.
  • Judged ineligible by physicians for participation in the study from a safety viewpoint.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498225

Locations
Japan
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
No.100, Tzyou 1st Rd., Kaohsiung, Taiwan, 807
Chang Gung Memorial Hospital, Kaohsiung
No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan, 833
Changhua Christian Hospital
No.135, Nanxiao St., Changhua, Taiwan, 500
National Cheng Kung University Hospital
No.138, Sheng Li Road,Tainan, Taiwan, 704
China Medical University Hospital
No.2, Yuh-Der Rd.,Taichung, Taiwan, 404
Taipei Veterans General Hospital
No.201, Sec. 2, Shih-Pai road, Taipei, Taiwan, 112
Chi Mei Medical Center Liou Ying Campus
No.201, Taikang Village, Liou Ying Township, Tainan, Taiwan, 736
Chang Gung Memorial Hospital, Lonkou
No.5, Fu-Hsing St. Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 333
National Taiwan University Hospital
No.7, Chung San South Road, Taipei, Taiwan, 100
Chi Mei Medical Center
No.901, Chung Hwa Rd., Yong Kang city, Tainan, Taiwan, 710
Mackay Memorial Hospital, Taipei
No.92, Sec. 2, Zhongshan N. Rd., Taipei, Taiwan, 104
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
TTY Biopharm
Investigators
Principal Investigator: Takuji Okusaka, MD National Cancer Center Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00498225     History of Changes
Other Study ID Numbers: 01023017
Study First Received: July 6, 2007
Last Updated: November 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014