Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

NCT00123825 | Completed Phase 2

• 1 other identifier: 02-065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

In the United States, the incidence of biliary tract cancer and gallbladder cancer has been estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for these tumors once the disease has spread and is inoperable. Recent small studies with gemcitabine have shown a positive response rate. The investigators plan to test the combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.

Conditions

Gallbladder Cancer; Biliary Tract Cancer

Keywords

Gallbladder; Biliary Tract; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• To determine the overall survival rate, progression-free survival rate, time to progression and duration of response

• To determine the toxicity of gemcitabine and cisplatin

• To assess the biomarker CA 19-9 response to the regimen and to correlate the CA 19-9 response with radiologic response and survival

Interventions

Gemcitabine DRUG

Cisplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Eli Lilly and Company: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Gallbladder Neoplasms; Biliary Tract Neoplasms; Cholangiocarcinoma

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jeffrey A Meyerhardt, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2005
• First Posted: July 26, 2005
• Study Start: July 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

US (3)