Phase 2 N=84 Randomized Treatment

Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

Biliary Tract Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00380588 ↗

Enrolled (actual)

Serious AEs

31.3%

Results posted

Nov 2009

Primary outcome: Primary: Percentage of Patients Alive at 1 Year (1-Year Survival Rate) — 39; 31 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: gemcitabine (Drug); cisplatin (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Alive at 1 Year (1-Year Survival Rate)	39; 31	—
SECONDARY Tumor Response	0; 0; 8; 5; 20; 16	0.380
SECONDARY Progression Free Survival	5.8; 3.7	0.074

Summary

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

Eligibility Criteria

Inclusion Criteria

Histological or cytological diagnosis of biliary tract cancer
Measurable disease must be at least one lesion
Chemotherapy-naïve
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Estimated life expectancy no less than 3 months

Exclusion Criteria

radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00380588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.