GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT00514163
First received: August 8, 2007
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine + S-1
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:
  • response rate [ Time Frame: during observation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • median survival time(MST) [ Time Frame: during observation ] [ Designated as safety issue: No ]
  • time-to-progression(TTP) [ Time Frame: from onset of regression to progression ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: during observation ] [ Designated as safety issue: Yes ]
  • clinical benefit response [ Time Frame: during observation ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
gemcitabine + S-1
Drug: gemcitabine + S-1
gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
Other Names:
  • gemzar
  • TS-1
Active Comparator: 2
S-1
Drug: gemcitabine
gemcitabine DIV on day one , 8th and 15th
Other Name: gemzar

Detailed Description:

Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically proven unresectable pancreatic carcinoma
  2. There must be measurable lesions with multislice CT
  3. ECOG Performance status 0-2
  4. No other active cancer
  5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
  6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
  7. No serious complications
  8. Be able to eat food
  9. Life expectancy of more than 8 weeks duration
  10. Informed consent is obtained-

Exclusion Criteria:

  1. Interstitial pneumonia
  2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
  3. Serious infection
  4. Pregnant or lactating females
  5. History of serious drug allergy
  6. Serious other complications
  7. Uncontrolled mental disorders -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514163

Locations
Japan
Cancer Institute Ariake Hospital
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Investigators
Principal Investigator: Takaaki Ikari, MD. PhD Cancer Institute Ariake Hospital
Principal Investigator: Masafumi Suyama, M.D. PhD Juntenndo University Hospital
Principal Investigator: Naoto Egawa, M.D. PhD Komagome Hospital
Principal Investigator: Yasuji Omuro, M.D. PhD Komagome Hospital
Principal Investigator: Takao Itoi, M.D. PhD Tokyo Medical college
Principal Investigator: Atsushi Sofuni, M.D. PhD Tokyo medical college
  More Information

No publications provided

Responsible Party: Takaaki Ikari, Cancer Institute Ariake Hospital
ClinicalTrials.gov Identifier: NCT00514163     History of Changes
Other Study ID Numbers: JACCRO PC-01
Study First Received: August 8, 2007
Last Updated: June 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Cancer Research Organization:
pancreatic carcinoma
gemcitabine
S-1
phaseⅡstudy

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 July 31, 2014