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

This study is currently recruiting participants.
Verified by Taiho Pharmaceutical Co., Ltd., July 2008

Sponsored by: Taiho Pharmaceutical Co., Ltd.
Information provided by: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00498225
  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 III

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    S 1 (Combination)   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

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 ]

Estimated Enrollment:   750
Study Start Date:   July 2007
Estimated Study Completion Date:   June 2013
Estimated Primary Completion Date:   June 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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.
2: Experimental
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.
3: Active Comparator
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 and older
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 or greater at registration.
  • 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

Contacts
Contact: Takuji Okusaka, MD     +81-3-3542-2511     tokusaka@ncc.go.jp    

Locations
Japan
National Cancer Center Hospital     Recruiting
      Tokyo, Japan, 104-0045
      Contact: Takuji Okusaka, MD     +81-3-3542-2511     tokusaka@ncc.go.jp    
      Contact: Hideki Ueno, MD     +81-3-3542-2511     hiueno@ncc.go.jp    
      Principal Investigator: Takuji Okusaka, MD            

Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.

Investigators
Principal Investigator:     Takuji Okusaka, MD     National Cancer Center Hospital    
  More Information


Publications:

Responsible Party:   Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:   01023017
First Received:   July 6, 2007
Last Updated:   July 27, 2008
ClinicalTrials.gov Identifier:   NCT00498225
Health Authority:   Japan: Ministry of Health, Labor and Welfare

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Disease Progression
Neoplasm Metastasis
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on October 06, 2008




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