Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00504192
Other study ID # SCH-GO-BTC1
Secondary ID
Status Completed
Phase Phase 2
First received July 18, 2007
Last updated May 19, 2014
Start date September 2006
Est. completion date March 2009

Study information

Verified date May 2009
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.


Description:

Treatment scheme

:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion

Each cycle is repeated every 2 weeks.

Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with histologically or cytologically confirmed biliary tract adenocarcinoma

2. Inoperable disease as defined by:

- Localized disease in a portion of the liver that does not allow the possibility of complete surgical removal of the tumor with a clear resection margin.

- Presence of metastatic lesion

- Unresectable recurrent tumor after curative resection

- anatomically resectable but inoperable associated with medical condition

3. Biliary obstruction controlled

4. Minimum life expectancy of 12 weeks.

5. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study

6. Age over 18 years

7. ECOG performance status of * 2.

8. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin =3xUNL; AST and/or ALT < 5x UNL; Creatinine< 1.5mg/dl or creatinine clearance >50 ml/mins

9. Consent form signed and dated prior to study specific procedures.

10. Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria:

1. Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification

2. Prior systemic chemotherapy

3. Subject with reproductive potential (M/F) not using adequate contraceptive measures.

4. Pregnancy and breast-feeding.

5. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).

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. Symptomatic or uncontrolled brain metastasis

8. Other concomitant anticancer agent, including Tamoxifen and Interferon.

9. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.

10. Participation in another clinical study or within 30 days before inclusion.

11. History of severe hypersensitivity reactions to gemcitabine or oxaliplatin

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine and Oxaliplatin
gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks

Locations

Country Name City State
Korea, Republic of Soonchunhyang University Bucheon Hospital Bucheon Kyunggi

Sponsors (1)

Lead Sponsor Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma every 4 cycles Yes
Secondary 1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate the time to progression and the duration of overall response. 3) To estimate overall tumor growth control rate (CR, PR plus SD). 4) To estimate overall survival. Overall survival is defined from the first day of treatment to the date of death. Time to progression is defined from the first day of treatment to the date of tumor progression assessed by CT scan or MRI. Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00944268 - Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety Phase 3
Recruiting NCT05580159 - New Generation mRNA Booster Vaccine Against Emerging VOCs Phase 3
Completed NCT05427305 - TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Phase 3
Active, not recruiting NCT05686161 - mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs Phase 3
Recruiting NCT06284746 - Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer Phase 2
Completed NCT04260113 - Apatinib for Inoperable Advanced Chondrosarcoma N/A
Recruiting NCT06120712 - A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002) Phase 1/Phase 2
Active, not recruiting NCT04002440 - Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight N/A
Recruiting NCT02693587 - Misodel or Angusta for Induction of Labour? N/A
Completed NCT01194453 - Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer Phase 2
Recruiting NCT05276557 - PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Phase 3
Recruiting NCT06205758 - Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Recruiting NCT06122454 - A Phase Ic/IIb Study to Evaluate the Efficacy,Safety and Pharmacokinetics of HST in Patients With CHB Phase 1/Phase 2
Recruiting NCT05913271 - Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
Recruiting NCT05999656 - Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot N/A
Recruiting NCT05731258 - Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Recruiting NCT03908138 - RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma Phase 4
Completed NCT05648799 - Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia) in Healthy Volunteers and Outpatients With COVID-19 N/A
Recruiting NCT03377933 - The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection N/A
Recruiting NCT04069780 - Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema N/A