Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage III Gallbladder Cancer AJCC v8
- Stage III Distal Bile Duct Cancer AJCC v8
- Stage III Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Extrahepatic Bile Duct Carcinoma
- Unresectable Intrahepatic Cholangiocarcinoma
- 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 IV Intrahepatic Cholangiocarcinoma AJCC v8
- Stage IIIB Gallbladder Cancer AJCC v8
- Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Gallbladder Carcinoma
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IVB Gallbladder Cancer AJCC v8
- Stage IVA Gallbladder Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 progres...
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.
Tracking Information
- NCT #
- NCT03768414
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rachna Shroff Southwest Oncology Group
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