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A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Cholangiocarcinoma, Gallbladder Adenocarcinoma

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Trial Information

A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)


It is considered realistic, that within 18 months 120 patients can be included in the
participating centers. Based on the previous publications an objective response rate (ORR)
of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is
between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a
two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB,
of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal
approximation will have a width between 15.4% and 16.7%. We assume an objective response
rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference
between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a
width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per
treatment arm).

Inclusion Criteria


Inclusion criteria:

- Cyto-/histological confirmed unresectable, locally advanced, or metastatic biliary
tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma or
adenocarcinoma of gallbladder, but NOT other peri-ampulla Vateri or mixed tumor.

- At least one, not previously irradiated, measurable lesion according to RECIST
(version 1.1).

- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.

- Aged no less than 20 years, at the time of acquisition of informed consent.

- Life expectancy >= 3 months.

- Adequate organ and bone marrow function as defined below: WBC >= 3.00 × 103/L and
absolute neutrophil count >= 1.50 × 103/L, Platelet count >= 100 × 103/L, Hemoglobin
level >= 10 g/dL, Serum creatinine <= 1.5 x Upper Normal Limit (UNL) and calculated
GFR >= 40mL/min, Serum bilirubin <= 1.5 x UNL , ALT <= 2.5x UNL.

- Ability to understand and willingness to sign written Informed Consent Form.

Exclusion criteria:

- Other anti-tumor agent such as systemic chemotherapy, immunotherapy or
EGFR/VEGF-pathway-targeting therapy before the commencement of study treatment.

- Radiotherapy (except palliative irradiation of bone lesions) within 4 weeks before
the commencement of study treatment.

- Other cancer or prior treatment for other carcinomas within the last five years,
except cured non-melanoma skin cancer and treated in-situ cervical cancer.

- Known CNS metastasis.

- Major surgery within 4 weeks prior to start of study treatment (diagnostic biopsy,
laparotomy, line placement is not considered as major surgery).

- Pre-existing peripheral neuropathy >= grade 2.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, myocardial infarction in the past 12
months, active gastrointestinal bleeding, central nervous system disorders or
psychiatric illness/social situation that would limit compliance with study
requirements or judged to be ineligible for the study by the investigator.

- Having received any investigational agents or participated in any investigational
drug study within 4 weeks prior to study enrollment.

- Pregnant or breast-feeding female (a pregnancy test must be performed on all female
patients who are of child-bearing potential before entering the study, and the result
must be negative).

- Poor compliance.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

objective response rate

Outcome Description:

Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.

Outcome Time Frame:

baseline and every 8 weeks

Safety Issue:

Yes

Principal Investigator

Li Tz Chen, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

National Institute of Cancer Research

Authority:

Taiwan: Institutional Review Board

Study ID:

T1210

NCT ID:

NCT01267344

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Cholangiocarcinoma
  • Gallbladder Adenocarcinoma
  • biliary tract cancer
  • BTC
  • cetuximaba
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Cholangiocarcinoma
  • Gallbladder Neoplasms
  • Biliary Tract Neoplasms

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