Trial | NCT00514163  Report issue

Title

GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
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
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.
Study Started
Jun 30
2007
Primary Completion
Aug 31
2010
Study Completion
Dec 31
2010
Last Update
Jun 28
2011
Estimate

Drug gemcitabine + S-1

gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks

  • Other names: gemzar, TS-1

Drug gemcitabine

gemcitabine DIV on day one , 8th and 15th

  • Other names: gemzar

1 Experimental

gemcitabine + S-1

2 Active Comparator

S-1

Criteria 

Inclusion Criteria:

Histologically or cytologically proven unresectable pancreatic carcinoma
There must be measurable lesions with multislice CT
ECOG Performance status 0-2
No other active cancer
No previous therapy such as radiotherapy, chemotherapy and immunotherapy
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
No serious complications
Be able to eat food
Life expectancy of more than 8 weeks duration
Informed consent is obtained-

Exclusion Criteria:

Interstitial pneumonia
Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
Serious infection
Pregnant or lactating females
History of serious drug allergy
Serious other complications
Uncontrolled mental disorders -
No Results Posted