A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Information source: Soonchunhyang University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Biliary Tract Adenocarcinoma; Gemcitabine; Oxaliplatin; Combination Chemotherapy; Efficacy
Intervention: Gemcitabine and Oxaliplatin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Soonchunhyang University Hospital Official(s) and/or principal investigator(s): Dae Sik Hong, professor, Principal Investigator, Affiliation: Soonchunhyang University Hospital
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.
Clinical Details
Official title: A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma
Secondary outcome: 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.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Soonchunhyang University Bucheon Hospital, Bucheon, Kyunggi 420-767, Korea, Republic of
Additional Information
Starting date: September 2006
Last updated: May 19, 2014
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