Know Cancer

forgot password

A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Phase 2
18 Years
Not Enrolling
Gallbladder Cancer, Biliary Tract Cancer

Thank you

Trial Information

A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Gemcitabine and cisplatin will be administered weekly for two weeks (on day 1 and day 8)
followed by a one week rest period (1 cycle is 3 weeks). On day one and eight of each cycle
the patient will have a physical exam and blood work. During the first two cycles,
additional blood work will be drawn on day 15 as well. Reassessment of the tumor will be
performed at 6 weeks, 12 weeks, and every 9 weeks thereafter. Patients will remain on
treatment until further evidence of disease progression or unacceptable side effects occur.

Inclusion Criteria:

- Histologically-confirmed, locally unresectable or metastatic biliary tract (bile
ducts, hepatic duct, cystic duct, common bile duct, ampulla of Vater) or gallbladder
adenocarcinoma. Patients must have at least one measurable lesion greater than 1 cm,
by Response Evaluation Criteria in Solid Tumors (RECIST) criteria outside of prior
radiation field.

- Zero to one prior chemotherapy for biliary tract or gallbladder cancer. Prior
chemoembolization to the liver allowed as long as measurable disease is outside of
chemoembolization area and other baseline characteristics are met. No prior
gemcitabine or cisplatin therapy allowed.

- No chemotherapy within past 3 weeks of initiation of therapy (6 weeks if prior
therapy was mitomycin C or nitrosurea)

- Chronological age > 18 years.

- ECOG performance status 0-2; life expectancy >12 weeks.

- Laboratory values: ANC greater than or equal to 1500/mm3; platelets greater than or
equal to 100,000/mm3; SGOT and SGPT less than or equal to 3x upper limits of normal
(unless liver is involved with tumor, in which case the transaminases must be less
than or equal to 5 x upper limits of normal); total bilirubin less than or equal to
2.0 mg/dL.

- Creatinine less than or equal to 1.8 mg/dL or creatinine clearance greater than or
equal to 50 mL/min

- All patients must sign informed consent.

- Patients may have prior placement of stents or shunts to relieve obstruction.

Exclusion Criteria:

- Patients with either clinically apparent central nervous system metastases or
carcinomatous meningitis.

- Myocardial infarction in the past six months.

- Major surgery in the past two weeks.

- Uncontrolled serious medical or psychiatric illness.

- Women must not be pregnant or lactating. Both men and women of childbearing
potential must be advised of the importance of using effective birth control measures
during the course of the study.

- Patients with concurrent malignancy of any site, except for limited basal cell
carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
patients with any other malignancy within 5 years of study entry, except for
curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers

Principal Investigator

Jeffrey A Meyerhardt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2002

Completion Date:

October 2007

Related Keywords:

  • Gallbladder Cancer
  • Biliary Tract Cancer
  • Gallbladder
  • Biliary Tract
  • Cholangiocarcinoma
  • Gallbladder Neoplasms
  • Biliary Tract Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617