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A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract

Inclusion Criteria:

- Male and female patients aged 18 years and older

- Signed and dated informed consent before the start of specific protocol procedures

- Adenocarcinoma of the gallbladder or intrahepatic bile ducts or histologically proven
hepatic metastases of an earlier resected and histologically proven biliary tract

- Not amenable to curative surgical resection

- With at least one unidimensionally measurable target lesion in non-irradiated
(or treated by photodynamic therapy, PDT) area (largest diameter ≥ 1 cm (spiral
CT scan or MRI) or ≥ 2 cm (conventional CT scan)

- With pain and biliary obstruction controlled

- Cytologically or histologically confirmed

- Note : in case of uncertain biliary tract origin (e.g., intrahepatic CCCs), inclusion
is possible if

- extensive search for primary tumor (thoracic and abdomino pelvic CT scan,
colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography
for women, and FDG-PET if possible) is negative

- histological examination is consistent with bile duct adenocarcinoma, with IHC
positive for cytokeratin 7 and 19 and negative for cytokeratin 20 [Shimonishi,

- No histological evidence of hepatocellular carcinoma (HCC)

- No prior palliative (radio)-chemotherapy (gemcitabine or fluoropyrimidine-based

- Note:

- previous adjuvant chemotherapy is allowed (completed since ≥ 6 months if
containing gemcitabine or platinum salts);

- previous irradiation (external radiotherapy, brachytherapy, chemoembolization)
and PDT are allowed, provided that there is at least one unidimensionally
measurable target lesion in untreated area

- Resolution of all side effects of prior surgical procedures to grade ≤ 1 (except for
the laboratory values specified below)

- At least 4 weeks from any major surgery (at first dose of study drug)

- ECOG Performance Status of 0-2

Exclusion Criteria:

- Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or PDT
within 30 days prior to start of treatment.

- Other tumor type than adenocarcinoma (e.g. leiomyosarcoma, lymphoma) or a second
cancer except in patients with squamous or basal cell carcinoma of the skin or
carcinoma in situ of the cervix which has been effectively treated. Patients
curatively treated and disease free for at least 5 years will be discussed with the
sponsor before inclusion

- History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI
more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring
anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled

- Any of the following within the 12 months prior to starting the study treatment,:
coronary/peripheral artery bypass graft, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism

- Ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc
interval > 450 msec for males or > 470 msec for females

- Hypertension that cannot be controlled by medications ( > 150/100 mmHg despite
optimal medical therapy)

- History of HIV infection

- Active clinically serious infections ( > grade 2 NCI-CTC version 3.0)

- Known Central Nervous System tumors including metastatic brain disease

- Patients with seizure disorder requiring medication (such as steroids or

- History of organ allograft

- Patients with evidence or history of bleeding diathesis

- Active disseminated intravascular coagulation, or patients prone to thromboembolism

- Patients undergoing renal dialysis

- Pregnant or breast-feeding patients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Markus Moehler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg University Mainz, I. Med. Klinik


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2008

Completion Date:

June 2010

Related Keywords:

  • Adenocarcinoma
  • advanced
  • metastatic
  • biliary
  • tract
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Biliary Tract Neoplasms