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CholangiocarcinomaPhase 2NCT02520141

Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

A Phase 2 study testing Laboratory Biomarker Analysis and Ramucirumab in people with Cholangiocarcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis and Ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
29 Dec 2015to 29 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma
  • Metastatic or unresectable disease documented on diagnostic imaging studies
  • Must have received at least one regimen containing gemcitabine chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Total bilirubin =< 1.5 mg/dL (25.65 mol/L)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times the upper limit of normal ([ULN]; or 5.0 times the ULN in the setting of liver metastases)
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  • Absolute neutrophil count (ANC) >= 1000/uL
  • Hemoglobin >= 9 g/dL (5.58 mmol/L)
  • Platelets >= 100,000/uL
  • The patient does not have:
  • Cirrhosis at a level of Child-Pugh B (or worse) or
  • Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Serum creatinine =< 1.5 times the ULN or
  • Creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed
  • The patient's urinary protein is =< 1 positive (+) (=< 30-100 mg/dl) on dipstick or routine urinalysis (urinary analysis [UA]; if urine dipstick or routine analysis is >= 2+ (>=100-300 mg/dl), a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol)
  • The patient must have adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and
  • Partial thromboplastin time (PTT) (PTT/activated partial thromboplastin time [aPTT]) < 1.5 x ULN)
  • Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
  • The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days
  • Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
  • In the ten patient expanded cohort, patients diagnosed with deoxyribonucleic acid (DNA) repair or FGFR genetic aberrations will be enrolled

Who cannot join

  • The patient has experienced any grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
  • Prior therapy with any agent targeting the vascular endothelial growth factor receptor (VEGFR) pathway to include bevacizumab, pazopanib, and other anti-angiogenesis inhibitors
  • The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism, including portal venous thrombosis (venous port or catheter thrombosis, incidental pulmonary embolism diagnosed on imaging studies or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization
  • The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
  • The patient has uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
  • The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
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  • The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
  • The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs ([NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
  • The patient has elective or planned major surgery to be performed during the course of the clinical trial
  • The patient is pregnant or breast-feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Ramucirumab for Advanced, Pre-Treated Biliary Cancers

This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the progression-free survival (PFS) of ramucirumab in advanced biliary cancers (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have received prior chemotherapy.

SECONDARY OBJECTIVES:

  1. Determine the response rate (RR) and disease control rate (partial response + complete response + stable disease) of ramucirumab in advanced biliary cancers.

II. Determine overall survival (OS) of ramucirumab in advanced biliary cancers. III. Evaluate the toxicity of ramucirumab in advanced biliary cancers.

EXPLORATORY OBJECTIVES:

  1. Correlate the carbohydrate antigen (CA) 19-9 response (defined as > 50% decrease from baseline) with tumor response, PFS and OS.

II. Correlate baseline tumor gene expression profile with PFS. III. Correlate pre- and post-therapy computed tomography (CT) imaging to quantify iodine content, atomic numbers, and Z-values and correlate with response.

OUTLINE:

Patients receive ramucirumab intravenously (IV) over 60 minutes on day 1. Courses repeat every 14 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.

Being tested
Laboratory Biomarker Analysis, Ramucirumab
Medical subject headings
Cholangiocarcinoma, Carcinoma, Hepatocellular, Gallbladder Neoplasms

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • RamucirumabBiological

    Also called anti-VEGFR-2 fully human monoclonal antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806

    Given IV

Study groups in NCT02520141
Study groupRoleWhat they receive
Treatment (ramucirumab)ExperimentalPatients receive ramucirumab IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Biological: Ramucirumab

What is being measured

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

  1. Progression Free Survival of Ramucirumab in Advanced Biliary Cancers

    Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment

    Measured: Up to 6 years

Secondary outcomes (3)

  1. Overall Survival (OS)

    Overal Survival (OS): the time from treatment initiation to death from any cause. OS functions were estimated using the Kaplan-Meier method .

    Measured: Up to 6 years

  2. Overall Response Rate (RR)

    The proportion of patients with the best overall response of complete response or partial response (PR)]

    Measured: Up to 6 years

  3. Percentage of Disease Control Rate

    Partial Response + Complete Response + Stable Disease (ORR + Stable Disease)

    Measured: Up to 6 years

Timeline

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

  1. First posted11 Aug 2015 (estimated)
  2. Study start29 Dec 2015
  3. Primary completion29 Jun 2022
  4. Study completion29 Jun 2022

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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520141
Sponsor's protocol ID
2015-0393
Other IDs
NCI-2015-01442, 2015-0393
Status last verified
May 2023
First submitted
5 Aug 2015
Last updated
15 Jun 2023

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Ramucirumab in people with Cholangiocarcinoma and Liver and Intrahepatic Bile Duct Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 22 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival of Ramucirumab in Advanced Biliary Cancers (time frame: Up to 6 years). 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 NCT02520141.

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 15 Jun 2023.

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