Conditions: Stage III Distal Bile Duct Cancer AJCC v8 Stage III Gallbladder Cancer AJCC v8 Stage III Intrahepatic Cholangiocarcinoma AJCC v8 Stage IIIA Distal Bile Duct Cancer AJCC v8 Stage IIIA Gallbladder Cancer AJCC v8 Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 Stage IIIB Distal Bile Duct Cancer AJCC v8 Stage IIIB Gallbladder Cancer AJCC v8 Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 Stage IV Distal Bile Duct Cancer AJCC v8 Stage IV Gallbladder Cancer AJCC v8 Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 Stage IVA Gallbladder Cancer AJCC v8 Stage IVB Gallbladder Cancer AJCC v8 Unresectable Extrahepatic Bile Duct Carcinoma Unresectable Gallbladder Carcinoma Unresectable Intrahepatic Cholangiocarcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief summary:
This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in patients with untreated, advanced biliary cancers treated with gemcitabine hydrochloride (gemcitabine) and cisplatin (GC) versus those treated with gemcitabine, cisplatin, and nab-Paclitaxel (GCN).

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in patients treated with GC versus GCN.

II. To compare overall response rate (ORR), complete and partial, confirmed and unconfirmed, in the subset of patients with measurable disease treated with GC versus GCN.

III. To compare disease control rate (confirmed and unconfirmed; complete response + partial response + stable disease) (DCR) in patients treated with GC versus GCN.

IV. To evaluate the frequency and severity of toxicity associated with GC and GCN in the patient population.

V. To explore the correlation between change in cancer antigen 19-9 (CA19-9) levels from baseline to post-treatment (after 3 cycles) and overall response rate, in each treatment arm separately and in the total cohort.

ADDITIONAL OBJECTIVES:

I. To bank tissue and blood for future translational medicine studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nab-paclitaxel 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.

ARM II: Patients receive 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 every 6 months for 2 years and then at the end of year 3.

Arms:
arm 1: Patients receive nab-paclitaxel 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. arm 2: Patients receive 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.

Interventions: intervention 1: Cisplatin intervention 2: Gemcitabine Hydrochloride intervention 3: Nab-paclitaxel
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV

Protocol document:
Prot_SAP_ICF_000.pdf: 
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