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Biliary Tract CancerPhase 2NCT02720601

Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

A Phase 2 study testing Irinotecan & Capecitabine in people with Biliary Tract Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Biliary tract cancers that progress after first line treatment can be difficult to treat. There is a great need for an effective, tolerable, easy to administer second-line regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Irinotecan & Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2015to Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Must be 18 years of age or older
  • Histological proven un-resectable or metastatic biliary tract cancer (gallbladder cancer included) with radiologic progression after initial gemcitabine plus platinum (cisplatin, carboplatin or oxaliplatin) regimen
  • Computerized tomography (CT) or magnetic resonance imaging (MRI) with measurable lesions no more than 28 days prior to enrollment. Lesions should be at least 1.5 cm in longest dimension.
  • Patients with evaluable only disease, effusion, needs to have cytology proven malignant cells present in the effusion.
  • Patients who cannot tolerate or developed allergic reaction to either gemcitabine or platinum compounds, even without radiographic progression will be eligible.
  • Patients must have a life expectancy of at least 12 weeks
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  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Patients must be able to understand and sign informed consent.
  • Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1,500 cells/mm3 and platelet count ≥ 60,000/mm3 and absence of a regular red blood cell transfusion requirement.
  • Patients should have adequate hepatic function with a total bilirubin ≤ 4.0 mg/dl, could be ≤ 10 mg/dl if a functional biliary drain is placed within three days of enrollment and documented declining total bilirubin level, and adequate renal function as defined by a serum creatinine ≤ 1.5 X upper limit of normal.
  • Patients with concurrent basal cell carcinoma and/or squamous cell carcinoma of skin are eligible.
  • Patients with other malignancies require having at least 5 year disease-free interval before enrollment
  • Patients who were treated with either irinotecan and/or capecitabine for cancers other than biliary tract cancer are eligible as long as treatment-free interval is greater than 3 years.

Who cannot join

  • Patients with symptomatic central nervous system (CNS) metastases are excluded. Need to demonstrate stable CNS metastases for at least 3 months
  • Pregnant women and nursing mothers are not eligible.
  • Patients of child bearing potential must agree to use adequate contraception
  • No heart attack within 6 months of enrollment
  • No stroke (embolic and hemorrhage) within 6 months of enrollment.
  • No New York Heart Association Class III/IV congestive heart failure (CHF).
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  • Severe chronic obstructive pulmonary disease (COPD) requires ≥ 2 L (Liters) /minute of oxygen.
  • Known history of allergic reaction to irinotecan and/or capecitabine.
  • Known history of 5-fluorouracil (5-FU) or capecitabine induced cardiac toxicity.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Universtiy of New Mexico - Cancer Center

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: A Phase II Trial of Combination Irinotecan and Capecitabine as Second-Line Treatment for Patients With Locally Advanced/Metastatic Biliary Tract Cancers Who Progressed or Intolerant to Front-Line Gemcitabine and Platinum Combination

Biliary tract cancers that progress after first line treatment can be difficult to treat. There is a great need for an effective, tolerable, easy to administer second-line regimen. Previous early phase studies demonstrated that the combination of two chemotherapy drugs, irinotecan and capecitabine had activity in this setting. The goal of this study is to determine whether this drug combination, as a second-line treatment, can improve progression free survival in patients with biliary tract cancers.

Read the detailed description

The current front-line treatment regimen using gemcitabine in combination with cisplatin has a significant survival benefit (11.7 versus 8.1 months, P < 0.001) in patients with biliary tract cancer when compare to single agent gemcitabine. However, there is urgent need for effective second-line regimens with minimal toxicity.

Capecitabine (Xeloda) is an oral pro-drug of 5-fluorouracil (5-FU). The conversion to active drug is dependent on thymidine phosphorylase, which is expressed at a higher level in tumor cells than in normal tissue. There are no reports on prospective clinical trials using capecitabine in cholangiocarcinoma. However, case reports of successful stabilization of disease with single agent capecitabine are available. Since 5-FU has been the main chemotherapy agent for biliary tract cancer for more than 40 years, it is reasonable to presume that the overall effectiveness of capecitabine will be very similar to infusional 5-FU.

Several clinical trials have shown that irinotecan can be a good agent for cholangiocarcinoma. Of the five patients that had a partial response in one phase I trial of the combination of irinotecan and docetaxel in advanced solid tumors, one had cholangiocarcinoma. Two of the 11 patients that had a partial response from another phase I trial using a combination of irinotecan, oxaliplatin and 5-FU in advanced tumors had cholangiocarcinoma. A case report indicated that single agent irinotecan given at a low weekly dose could produce a long-lasting response in metastatic cholangiocarcinoma.

Based on the above data, our experience, and other early phase studies of this combination, this phase II trial was proposed to determine the progression free survival, response rate, overall survival, and toxicity in biliary tract cancer patients who are administered irinotecan and capecitabine as a second-line treatment.

Being tested
Irinotecan & Capecitabine
Keywords
irinotecan, capecitabine, gemcitabine, biliary tract cancer, gallbladder cancer, second-line
Medical subject headings
Biliary Tract Neoplasms, Gallbladder Neoplasms

What participants receive

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

  • Irinotecan & CapecitabineDrug

    Also called Irinotecan = Camptosar, Campto, or CPT-11 (Camptothecin-11), Capecitabine = Xeloda

    Irinotecan will be administered at infusion room over 60 minutes. Capecitabine will be administered by the patients at home. Unless there is early progression of disease, at least two courses will be administered to each patient. Repeated courses may be given to the patients who benefit from the treatment (either complete or partial remission, or stabilization of disease)

Study groups in NCT02720601
Study groupRoleWhat they receive
Irinotecan & CapecitabineExperimentalIrinotecan at 120 mg/m2 intravenously every three weeks + Capecitabine at 1500 mg/m2/day orally twice per day for a total of 14 days. The treatment cycle is once every 21 days.
Receives: Drug: Irinotecan & Capecitabine

What is being measured

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

  1. Progression-free survival (PFS)

    The time from initiation of treatment to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.The Kaplan-Meier method will be used to calculate the proportion of subjects who are progression-free at 6 months along with its 95% confidence interval. Subjects lost to follow-up or who withdraw from the study for any reason will be censored at their last date of contact

    Measured: 6 months from the time of initiating treatment

Secondary outcomes (3)

  1. Overall response rate (ORR)

    Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (PR): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Best overall response is the best response recorded from the start of treatment until disease progression/recurrence. (For definition of progression, see Outcome Measure 1). Overall response rate will be reported as the sum of the percentages of patients achieving CR and PR.

    Measured: Up to 6 months after initiating treatment

  2. Overall Survival (OS)

    The time from study enrollment to death by any cause. Subjects who withdraw from the study for any reason or are lost to follow-up will be censored at their last date of contact. The Kaplan-Meier method will be used to calculate the median OS and 95% confidence interval

    Measured: 36 months from enrollment

  3. Toxicity

    Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0. Adverse events of grade 3 or higher will be reported as percentages of patients affected. If subjects experience the same toxicity more than once, the subjects' highest grade toxicity will be used for summaries.

    Measured: Up to 30 days after last on-study treatment

Timeline

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

  1. First posted28 Mar 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionMar 2020 (estimated)

Why it stopped: Study was never submitted to the IRB \& never opened. PI is leaving institution.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720601
Sponsor's protocol ID
INST 1417
Status last verified
Jan 2018
First submitted
23 Mar 2016
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan & Capecitabine in people with Biliary Tract Cancer, run by New Mexico Cancer Research Alliance 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 13 inclusion and 9 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: withdrawn, as of the sponsor's last update on 25 Jan 2018. 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?

The study was withdrawn before enrolling participants, so there are no results.

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 (PFS) (time frame: 6 months from the time of initiating treatment). 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 NCT02720601.

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 25 Jan 2018.

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