NCT02392637

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Determine the progression-free survival (PFS) of gemcitabine hydrochloride (gemcitabine), cisplatin, and nab-paclitaxel in advanced, untreated biliary cancers (intrahepatic cholangiocarcinomas, extrahepatic cholangiocarcinomas, and gallbladder cancers). SECONDARY OBJECTIVES: I. Determine the response rate (RR) and disease control rate (partial response + complete response + stable disease) of gemcitabine, cisplatin, and nab-paclitaxel in advanced biliary cancers. II. Determine overall survival (OS) of gemcitabine, cisplatin, and nab-paclitaxel in advanced biliary cancers. III. Evaluate the toxicity of gemcitabine, cisplatin, and nab-paclitaxel in advanced biliary cancers. EXPLORATORY OBJECTIVES: I. Correlate the carbohydrate antigen (CA) 19-9 response (defined as \>50% decrease from baseline) with tumor response, PFS and OS. II. Assess ribonucleotide reductase subunit MI (RRMI), excision repair cross-complementation group 1 (ERCC1) pre-treatment status and correlate with tumor response, PFS and OS on an exploratory basis. III. Collect optional blood and tissue at the start of treatment and at progression to explore mechanisms of resistance. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Conditions

• Stage III Intrahepatic Cholangiocarcinoma AJCC v7
• Stage IIIA Gallbladder Cancer AJCC v7
• Stage IIIB Gallbladder Cancer AJCC v7
• Stage IVA Gallbladder Cancer AJCC v7
• Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7
• Stage IVB Gallbladder Cancer AJCC v7
• Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7
• Unresectable Extrahepatic Bile Duct Carcinoma
• Unresectable Gallbladder Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nab-paclitaxel	Given IV

Timeline

• Start date: 2015-04-02
• Primary completion: 2020-08-13
• Completion: 2020-08-13
• First posted: 2015-03-19
• Last updated: 2022-02-02
• Results posted: 2022-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study