GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514163
• Other study ID #: JACCRO PC-01
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: June 27, 2011
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Japan Clinical Cancer Research Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine + S-1
gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
• gemcitabine
gemcitabine DIV on day one , 8th and 15th

Locations

Country	Name	City	State
Japan	Cancer Institute Ariake Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Clinical Cancer Research Organization

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		during observation	No
Secondary	median survival time(MST)		during observation	No
Secondary	time-to-progression(TTP)		from onset of regression to progression	No
Secondary	toxicity		during observation	Yes
Secondary	clinical benefit response		during observation	No