Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02392637|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cisplatin Drug: Gemcitabine Hydrochloride Other: Laboratory Biomarker Analysis Drug: Nab-paclitaxel||Phase 2|
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).
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers|
|Actual Study Start Date :||April 2, 2015|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation 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.
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
- Progression free survival (PFS) [ Time Frame: Up to 3 years ]The Bayes factor single arm time-to-event model by Johnson & Cook will be used to monitor the PFS time.
- Incidence of adverse events [ Time Frame: Up to 35 days post-treatment ]Toxicity will be monitored closely using the method of Thall et al.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392637
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Milind Javle||M.D. Anderson Cancer Center|