Experimental Combination of Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel For Advanced Biliary Tract Cancers

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Advanced Biliary Tract Cancer, Biliary Tract Cancer
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
Biliary cancer is a form of cancer that develops in the bile duct system. This system connects the liver, gallbladder, and small intestine. The biliary ducts move bile, a fluid that helps digest fats, to the small intestine.

The purpose of this study is to compare the effects of an experimental combination treatment. I twill be used to treat newly Diagnosed, Advanced Biliary Tract Cancers.

The drug nab-paclitaxel will be added to standard treatment with the drugs cisplatin and gemcitabine. This treatment will be compared to treatment with cisplatin and gemcitabine alone.

Nabpaclitaxel is an FDA-approved drug for other diseases. It is experimental in this study. The addition of the study drug nab-paclitaxel could shrink your cancer. It could also cause side effects.

This study will help the study team learn whether this different approach is better, the same, or worse than standard treatment.

In this study, you will get either:
- cisplatin and gemcitabine, or
- nab-paclitaxel with cisplatin and gemcitabine.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Disease Related Criteria a. Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. NOTE: Pathology report must be uploaded in Rave. Histology report must be consistent with an adenocarcinoma with pancreaticobiliary primary assuming there are no pancreatic lesions and other primaries are ruled out per local standard. b. Patients must have documented metastatic or locally advanced unresectable disease on CT or MR imaging CT scans or MRIs used to assess measurable disease. must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. c. Patient must not have a current diagnosis of ampullary cancer.

Prior/Concurrent Therapy Criteria a. Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer. b. Patient must not have received adjuvant therapy within 6 months prior to registration.

Clinical/Laboratory Criteria a. Patients must have a complete medical history and physical exam within 28 days prior to registration. b. Patients must be ≥ 18 years of age. c. Patients must have a Zubrod Performance Status of 0 or 1. d. Patients must not have a history of peripheral neuropathy of Grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 Grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs)” e. Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/mcL; platelets ≥ 100,000/mcL; Hemoglobin ≥ 8 g/dL, and serum albumin ≥ 2.8 g/dL. These results must be obtained within 28 days prior to registration. f. Patients must have adequate hepatic function as evidenced by the following: total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s Syndrome, who must have a direct bilirubin < 1.5 mg/dL), and SGOT (AST) and SGPT (ALT) ≤ 8 x IULN. These results must be obtained within 28 days prior to registration. g. Patients must have adequate renal function as evidenced by ONE of the following: serum creatinine ≤ IULN OR calculated creatinine clearance ≥ 60 mL/min. This serum creatinine result must have been obtained within 28 days prior to registration. h. Patients must have CA19-9 obtained within 42 days prior to registration. i. Patients must have sodium, potassium, bicarbonate, chloride, BUN, calcium, total protein, magnesium, and alkaline phosphatase obtained within 28 days prior to registration. j. Patients must not have an active infection requiring systemic therapy. k. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years. l. Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.

Specimen Submission Criteria a. Sites must seek additional patient consent for the future use of specimens.

Regulatory Criteria a. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. b. As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
After you finish your study treatment, your doctor will continue to follow your condition for up to three years. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits every six months from the time you stop taking treatment for two years. You will have another clinic visit at the end of the 3rd year.
Recruitment period
From Jan. 29, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
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

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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