Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma

Completed · Phase 2

Conditions studied: Cholangiocarcinoma

In brief

Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.

Key facts

Study ID

NCT02181634

Run by

PrECOG, LLC.

People needed

74

Starts

2014-12-09

Expected to finish

2017-10-01

Last updated by the study team

2018-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed.
• Must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a Radiologist, is acceptable.
• May have received prior radiation, chemoembolization, radioembolization, or other local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to registration AND if patient has recovered to ≤ grade 1 toxicity. NOTE: Measurable disease (as required above) must still be present.
• May have received prior radiation for bone or brain metastases if patient is now asymptomatic and has completed all radiation and steroid therapy (if applicable) ≥ 2 weeks prior to registration.
• Age ≥ 18 years.
• Child-Pugh score of A or B with ≤ 7 points.
• Eastern Cooperative Oncology Group performance status of 0-1.
• Willing to provide archived tissue, if available, from a previous diagnostic biopsy.
• Must be able to tolerate CT and/or MRI with contrast.
• Adequate organ function obtained ≤ 2 weeks prior to registration:
• Absolute Neutrophil Count ≥ 1500/mm³
• Hemoglobin ˃9.0 g/dL
• Platelets ˃100,000/mm³
• Serum Creatinine ≤ 1.5x Upper Limit Normal (ULN)
• Creatinine Clearance ≥ 50 mL/min
• Albumin ≥ 2.8 g/dL
• Total Bilirubin ≤ 1.5 mg/dL or ≤ 1.5x ULN
• Aspartate Aminotransaminase (AST)/Alanine Aminotransaminase (ALT) ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
• International Normalized Ratio (INR) <1.5x the ULN [INR ≥ 1.5 is allowed if anticoagulation is used.]
• Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine may harm the fetus or child.
• Must not have received prior systemic cytotoxic chemotherapy or targeted therapy for this cancer.
• Must not be receiving treatment with other investigational agents.
• Must not have a pre-existing >grade 2 peripheral neuropathy.
• Must not be receiving immunosuppressive medications, including systemic corticosteroids, aside from the following exceptions: used for adrenal replacement, appetite stimulation, therapy for asthma, bronchitis exacerbation (≤ 2 weeks), anti-emesis, or pre-medication for procedures (i.e. CT scan).
• No known Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) seropositivity.

Where it is running

• Colorado Cancer Research Program — Denver, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Siouxland Hematology-Oncology Associates — Sioux City, Iowa, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• St. Joseph Mercy Health System — Ann Arbor, Michigan, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Metro Minnesota CCOP — Saint Louis Park, Minnesota, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Mount Sinai Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pennsylvania; Abramson Cancer Center at Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States
• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Gundersen Health System — La Crosse, Wisconsin, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States
• Aurora Cancer Care — Wauwatosa, Wisconsin, United States
• Medical University of Vienna — Vienna, Austria

Full record on ClinicalTrials.gov

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