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

Lilly

Status and phase: Completed; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: cisplatin; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380588

10298

B9E-JE-BT22

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

84 participants in 2 patient groups

Gemcitabine + Cisplatin

Experimental group

Description:

Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Treatment:

Drug: cisplatin

Drug: gemcitabine

Gemcitabine

Experimental group

Description:

Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Treatment:

Drug: gemcitabine