Second Line Therapy in Advanced Biliary Tract Cancer

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Brief Title

Second Line Therapy in Advanced Biliary Tract Cancer

Official Title

A Randomized Phase II Trial of Second Line Therapy in Advanced Biliary Tract Cancer: Capecitabine or Capecitabine Plus Mitomycin C

Brief Summary

      The purpose of this study is to assess the therapeutic activity of capecitabine alone or in
      combination with mitomycin C as second-line therapy in patients with advanced/metastatic
      biliary adenocarcinoma in progression after gemcitabine and platinum compounds
    

Detailed Description

      Biliary tract adenocarcinoma is an uncommon tumor with a poor prognosis and a median overall
      survival (OS) rarely exceeding 6 months. Less than 25% of patients are resectable at
      diagnosis and, even in this subset of patients, relapse rate is high. An improvement of OS
      and quality of life for patients receiving chemotherapy versus best supportive care was
      demonstrated in advanced disease. Recently, cisplatin and gemcitabine combination was
      identified as the new standard first-line chemotherapy, yielding a median progression free
      survival (PFS) and median OS of 8.5 and 11.7 months, respectively. Despite the outcome
      improvement, disease progression is a constant and approximately half of patients failing
      upfront treatment has a good performance status and are willing to undergo further treatment.
      No standard salvage chemotherapy regimen has been identified. Clinical trials are difficult
      to perform due to the rarity and heterogeneity of these tumors and to the lack of interest of
      the pharmaceutical industry. Fluoropyrimidines and mitomycin C have been considered the basis
      of palliative chemotherapy for a long time. The investigators decided to explore the
      activity, in terms of PFS, of capecitabine alone or combined with mitomycin C as second-line
      therapy in patients with pathological diagnosis of advanced biliary tract cancer and
      progressive disease after gemcitabine and cisplatin, by means of an open label randomized
      multicentric phase II trial.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression Free Survival (PFS)

Secondary Outcome

 Overall Survival (OS)

Condition

Biliary Tract Cancer

Intervention

capecitabine and mitomycin

Study Arms / Comparison Groups

 capecitabine
Description:  oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

52

Start Date

November 2011

Completion Date

October 2013

Primary Completion Date

October 2013

Eligibility Criteria

        Inclusion Criteria:

          1. Signed and dated IRB/IEC-approved Informed Consent.

          2. Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma
             of the biliary tract (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary
             ducts).

          3. Disease progressing after first-line chemotherapy with gemcitabine and platinum
             analogs (only one prior systemic therapy allowed).

          4. Age 18-75 years

          5. Karnofsky Performance Status > 50%

          6. Estimated life expectancy of at least 3 months.

          7. Negative pregnancy test (if female in reproductive years).

          8. Adequate bone marrow, liver and kidney function: leukocyte > 3500/mm3; absolute
             neutrophil count (ANC) > 1500/mm3; platelet count > 100000/mm3; hemoglobin > 10 g/dl;
             creatinine < 1.5 mg/dL; total bilirubin ≤ 1.5 x upper limit of normal range (ULN);
             SGOT e SGPT ≤ 2.5 ULN

          9. At the time of start of treatment, at least 2 weeks must have elapsed since completion
             of prior chemotherapy, minor surgery and radiotherapy (provided that no more than 25%
             of bone marrow reserve has been irradiated).

         10. Resolution of all acute toxic effects of any prior chemotherapy, surgery or
             radiotherapy to NCI CTC (Version 4.03) grade ≤ 1 for hematologic toxicities and ≤ 2
             for non hematologic toxicities, with the exception of alopecia.

         11. Able and willing to comply with scheduled visits, therapy plans, and laboratory tests
             required in this protocol.

        Exclusion Criteria:

          1. Previous or concurrent malignancies at other sites with the exception of surgically
             cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin
             and of other neoplasm without evidence of disease at least from 5 years.

          2. Known brain metastases.

          3. Previous second-line or adjuvant treatment.

          4. Concurrent treatment with other experimental drugs.

          5. Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, cardiac arrhythmia) ≤1 year
             prior to dosing.

          6. Clinically significant disease including: Cerebral Vascular Accident; other serious
             underlying medical condition(s) which could impair the ability of the patient to
             participate in the study.

          7. History of interstitial lung disease (eg, pneumonia or pulmonary fibrosis) or evidence
             of interstitial lung disease on baseline chest CT scan

          8. Known positive tests for human immunodeficiency virus (HIV) infection, active
             hepatitis B or hepatitis C

          9. Subject who is pregnant or breast feeding

         10. Woman or man of child-bearing potential not consenting to use adequate contraceptive
             precautions ie. double barrier contraceptive methods (e.g., diaphragm plus condom), or
             abstinence during the course of the study and for 6 months after the last study drug
             administration for women, and 1 month for men

         11. Presence of any psychological, familial, sociological or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

stefano cereda, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01530503

Organization ID

2011-002002-70


Responsible Party

Principal Investigator

Study Sponsor

IRCCS San Raffaele

Collaborators

 Regione Lombardia

Study Sponsor

stefano cereda, MD, Principal Investigator, Ospedale San Raffaele (Milan, Italy)


Verification Date

February 2016