A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer

NCT02632305 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: AX-CSARC-PI-0001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There is no other known treatment for biliary cancer that has spread to other organs. It is hoped that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve the tumor shrinkage rate. This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better to treat biliary cancers. We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in patients with biliary cancer can increase tumor shrinkage without too many side effects. The purpose of this study is to find out what effects (good and bad) nab-paclitaxel, gemcitabine, and cisplatin has on you and your biliary cancer.

Conditions

Unresectable Biliary Tract Cancer

Keywords

unresectable biliary tract cancer; nab-paclitaxel; cisplatin; gemcitabine

Outcome Measures

Primary Outcomes (1)

• Overall response rates

  defined as the sum of complete response rates and partial response rates, of nab-paclitaxel in combination with gemcitabine + cisplatin in first line treatment of unresectable biliary tract cancer (BTC).

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Eligible patients will receive nab-paclitaxel in combination with gemcitabine + cisplatin at the recommended phase II dose based on the phase I study completed in metastatic pancreas cancer patients. The doses of study drugs will be as follows: * nab-Paclitaxel 100 mg/m2 day 1 and 8 every 21 days * Cisplatin 25 mg/m2 day 1 and 8 every 21 days * Gemcitabine 800 mg/m2 day 1 and 8 every 21 days Nab-paclitaxel will be administered first followed by cisplatin and then gemcitabine on day 1 and 8 of each treatment cycle. Cycles will be 3 weeks in length (21 days).

Drug: nab-paclitaxel in combination with gemcitabine + cisplatin

Interventions

nab-paclitaxel in combination with gemcitabine + cisplatin DRUG

Patients with unresectable BTC will be treated with the triple combination of nab-paclitaxel in combination with gemcitabine + cisplatin

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented locally advanced or metastatic BTC (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) not previously treated with palliative systemic therapy or radiation
• Unresectable disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST 1.1. Patients must have measurable disease; evaluable only disease will not be permitted.
• ECOG performance status of 0 - 1.
• Age ≥ 18 years.
• Life expectancy of at least 3 months based on discretion of treating oncologist.
• Adequate hematologic function defined by the following laboratory parameters:
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100 x 109/L
• Absolute granulocyte count ≥ 1.5 x 109/L
• Adequate hepatic and renal function defined by the following laboratory parameters:
• AST and ALT and alkaline phosphatase ≤ 2.5 X upper limit of institutional normal (≤ 5 if liver metastases)
• bilirubin ≤ 1.5 X upper limit of institutional normal
• serum creatinine ≤ upper limit of institutional normal OR calculated creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault formula
• Patients may have received prior surgery if this surgery was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
• Prothrombin time- international normalized ratio (PT-INR) and partial thromboplastin time (PTT) must be within +/- 15% normal range.

You may not qualify if:

• Patients who have received prior palliative chemotherapy for their advanced BTC.
• Prior curative or palliative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores.
• History of bowel obstruction due to peritoneal metastases or clinically documented ascites requiring paracenteses.
• Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or uterus or non-melanoma skin cancer or in-situ carcinoma of the prostate (Gleason score ≤ 7, with all treatment being completed 6 months prior to enrollment, unless at least 5 years have elapsed since last treatment and the patient is considered cured).
• Active bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
• Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
• Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment.
• Pre-existing neuropathy ≥ grade 1 from any cause.
• Patients with unstable metastasis to the central nervous system (CNS). A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement.
• Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs.
• History of allergic reaction to planned study medications.
• Patient has a ≥ 20% decrease in serum albumin level between baseline visit, if available, and within 72 hours prior to first study treatment dose.
• Patient is on coumadin.
• History of interstitial lung disease.
• History of connective tissue disorders (e.g. lupus, scleroderma, polyarteritis nodosa).

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Celgene: collaborator

Study Sites (2)

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jennifer Spratlin, MD FRCPC

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: July 13, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)