SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer

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Brief Title

SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer

Official Title

Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer

Brief Summary

      This is an exploratory, single-armed, open label study on the efficacy and safety of
      sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary
      system or periampullary cancer or pancreatic cancer patients. The primary endpoint is
      Objective response rate and secondary endpoint is progression free survival , overall
      survival ,1 year survival rate and safety.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate for SOX sequential S-1

Secondary Outcome

 Overall Survival

Condition

Biliary Tract Cancer

Intervention

SOX sequential S-1

Study Arms / Comparison Groups

 SOX sequential S-1
Description:  4-6 cycles of SOX followed by S-1 monotherapy until disease progression

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

July 2010

Completion Date

July 2014

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Written Informed consent

          -  Male or female patients >=18 years old

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma

          -  No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or
             others.

          -  In case the patient received adjuvant therapy before, enrollment is allowed if the
             adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of
             chemotherapy is ≥180 days before screening.

          -  Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before
             enrollment

          -  The laboratory parameter meets the following criteria 7 days before enrollment

               -  Hemoglobin ≥90g/L

               -  Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L;

               -  ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0
                  ULN)

               -  ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)

               -  Total Serum bilirubin ≤1.5 ULN

               -  Serum creatinine ≤1.0 ULN

               -  serum albumin(ALB)≥30g/L;

          -  can tolerate oral drug administration;

          -  KPS ≥70

          -  Estimated survival ≥90 days

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days of enrollment and must be willing to use adequate methods of
             contraception during the study and for 30 days after last study durg administration.

        Exclusion Criteria:

          -  Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment
             agents including irinotecan, cisplatin and octreotide lar

          -  Any participation in trials simultaneously or 4 weeks before screening.

          -  15 days prior to enrollment, received a blood transfusion, blood products and
             hematopoietic growth factors such as G-CSF.

          -  Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not
             recovered from side effects of such surgery.

          -  Uncontrolled severe diarrhea

          -  Uncontrolled active infection (fever ≥38 degrees due to infection)

          -  S-1 oral drug administration difficulty due to difficulty swallowing, complete or
             incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation;

          -  severe hepatopathy including active hepatitis and hepatic cirrhosis, renal
             dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary
             fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other
             chronic systematic diseases.

          -  Chronic treatment with steroids.(In case of the patients with short-term use of
             steroids, the enrollment is permitted if the administration is stopped 2 weeks before
             screening.)

          -  confirmed or suspected CNS metastasis

          -  the history of peripheral nervous system impairment, obvious mental disorder or CNS
             impairment

          -  clinically significant heart disease, including congestive heart failure, symptomatic
             coronal heart disease, arrythmia uncontrolled by medication and acute myocardial
             infarction or cardiac insufficiency within 6 months before screening

          -  Drainage of pleural effusion, peritoneal effusion and pericardial effusion

          -  pregnant women or women in lactation period

          -  Fertile male or women of child-bearing potential refuse to take highly effective
             methods of birth control

          -  Incidence of other second primary malignant tumors within 5 years, except for cured
             basal cell carcinoma and cervical carcinoma in situ.

          -  patients of legal incapacity or who have the potential of influence the whole trial
             due to medical or ethic reasons.

          -  Other patients who are not eligible to the trial under investigators' discretion
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lin Shen, Prof., +86 10 88196175, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01811277

Organization ID

SOX-S-1 BTC


Responsible Party

Principal Investigator

Study Sponsor

Peking University

Collaborators

 Taiho Pharmaceutical Co., Ltd.

Study Sponsor

Lin Shen, Prof., Principal Investigator, Beijing Cancer Hospital


Verification Date

July 2010