Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer

NCT01171755 | Terminated Phase 2 DMC

• 2 other identifiers: 2007-11-00882-02-3410-0914
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  1year 6months

Study Arms (1)

Gemcitabine, Ts-1

EXPERIMENTAL

Gemcitabine : 1000/m2 will be administered on days 1 and 8 at every 3 weeks . TS-1 will be administered orally according to body surface area (BSA) as follows : BSA\<1.25 M2, 80 mg/day; 1.25 M2≤BSA\<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.

Drug: Gemcitabine TS-1

Interventions

Gemcitabine TS-1 DRUG

Gemcitabine (1,000mg/m2) will be administered on days 1 and 8 at every 3 weeks TS-1 will be administered orally according to body surface area (BSA) as follows : BSA\<1.25 M2, 80 mg/day; 1.25 M2≤BSA\<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.

Also known as: Gemcitabine (Gemza)TS-1 (TS-1)

Gemcitabine, Ts-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Pathologically proven, measurable, unresectable, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder or papilla of Vater 2. No prior chemotherapy for advanced disease was allowed 3. No concurrent radiotherapy 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 5. At least 18 years old 6. ECOG performance status of ≤ 2 7. Adequate organ function as evidenced by the following; Absolute neutophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; hemoglobin \> 10g/dL; INR ≤ 1.4; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; albumin \> 3g/dL or \> 30µmol/L; creatinine clearance ≥ 50mL/minInformed consent signed 8. Subject able to comply with the scheduled follow-up and the management of toxicities

You may not qualify if:

• \. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of TS-1 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) 2. Subject with reproductive potential (male or female) not using adequate contraceptive measures 3. Pregnancy and breast-feeding 4. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics) 5. History of significant cardiac disease, arrhythmias and angina pectoris 6. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix 7. Other concomitant anticancer agent 8. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons 9. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yeong Lim Lim, Professor

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 21, 2014

Record last verified: 2012-01