Clinical trial NCT00514163: GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Official title: Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: pancreatic carcinoma
gemcitabine
S-1
phaseⅡstudy
Lead sponsor: Japan Clinical Cancer Research Organization
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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 -

Primary outcomes:
measure: response rate
timeFrame: during observation
Secondary outcomes:
measure: median survival time(MST)
timeFrame: during observation
measure: time-to-progression(TTP)
timeFrame: from onset of regression to progression
measure: toxicity
timeFrame: during observation
measure: clinical benefit response
timeFrame: during observation
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Cancer Institute Ariake Hospital
Study officials:
affiliation: Cancer Institute Ariake Hospital
name: Takaaki Ikari, MD. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juntenndo University Hospital
name: Masafumi Suyama, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Komagome Hospital
name: Naoto Egawa, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Komagome Hospital
name: Yasuji Omuro, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo Medical college
name: Takao Itoi, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo medical college
name: Atsushi Sofuni, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References: