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Unresectable Biliary Tract CancerPhase 2AX-CSARCNCT02632305

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

A Phase 2 study testing nab-paclitaxel in combination with gemcitabine + cisplatin in people with Unresectable Biliary Tract Cancer, run by AHS Cancer Control Alberta at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Biliary Tract Cancer
What is being tested?
nab-paclitaxel in combination with gemcitabine + cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesCanada
Study dates
13 Jul 2016to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Patients who have treated brain metastasis (via local radiation standards or surgical resection or local ablative techniques) and who are either off steroids or on a stable dose of steroids for at least one month (30 days), AND who are off anticonvulsants, AND have radiological documented stability of lesions for at least 3 months may be eligible. Each case should be discussed with the study Chair.
  • Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
  • Female subjects of childbearing potential, defined as a sexually mature woman who 1) has not undergone hysterectomy or bilateral oophorectomy OR 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months) must:
  • either commit to true abstinence or agree to the use of a 2 physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive with spermicide; or vasectomized partner) while on clinical trial and for at least 3 months following the last does of study medication; and
  • has a negative serum pregnancy test (β-hCG) result at screening. Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 6 months following study medication discontinuation, even if he has undergone a success vasectomy.

Who cannot join

  • 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.
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  • 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).
  • Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent the subject from participating in the study, places the subject at unacceptable risk if he/she were to participate in the study, or any condition that confounds the ability to interpret data from the study.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Multicentre, Open-label Phase II Study of Nab-paclitaxel in Combination With Gemcitabine + Cisplatin as First Line Treatment in Patients With Unresectable Biliary Tract Cancer

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.

Read more

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.

Read the detailed description

There is increasing evidence that there is a large degree of pathologic homology between the pancreas and biliary tract. Indeed, the biliary tract has been referred to as "an incomplete pancreas" and embryologically the two originate from the same structure. It is thus plausible that oncogenesis in the pancreas and biliary tract are related and that pancreas and biliary cancers have reciprocal effective treatment strategies.

To date, the only chemotherapeutic agents effective in advanced biliary tract tumors is the combination of gemcitabine and cisplatin. Known and approved therapies for advanced pancreas cancer include single agent gemcitabine, the four drug combination of FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin, and irinotecan), the questionable limited benefit of inhibiting the epidermal growth factor receptor pathway, and most recently the combination of gemcitabine and nab-paclitaxel.

Based on promising results in pancreas cancer, investigators hypothesize nab-paclitaxel in combination with gemcitabine + cisplatin will be an effective cytotoxic combination in BTC treatment.

Being tested
nab-paclitaxel in combination with gemcitabine + cisplatin
Keywords
unresectable biliary tract cancer, nab-paclitaxel, cisplatin, gemcitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-paclitaxel in combination with gemcitabine + cisplatinDrug

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

Study groups in NCT02632305
Study groupRoleWhat they receive
TreatmentExperimentalEligible 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).
Receives: Drug: nab-paclitaxel in combination with gemcitabine + cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2015 (estimated)
  2. Study start13 Jul 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02632305
Sponsor's protocol ID
AX-CSARC-PI-0001
Acronym
AX-CSARC
Status last verified
Jun 2025
First submitted
14 Dec 2015
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-paclitaxel in combination with gemcitabine + cisplatin in people with Unresectable Biliary Tract Cancer, run by AHS Cancer Control Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rates (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02632305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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