Second Line Therapy in Advanced Biliary Tract Cancer

NCT01530503 | Completed Phase 2 DMC

• 1 other identifier: 2011-002002-70
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 16

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

Conditions

Biliary Tract Cancer

Keywords

biliary tract cancer; advanced disease; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  This is a multi-centre phase II, randomized study. Patients will be stratified based on disease site and stage. For the purpose of the study, PFS-6 rate will be considered the primary outcome measure. The maximum PFS-6 rate of low clinical interest is 15% and the minimum PFS-6 rate of interest is set to 35%. The target enrollment, using a type I error of 5% and a test power of 90%, will be estimated to be 26 patients per treatment arm. The regimen will be considered active if at least 8 out of first 26 evaluable patients are PFS-6.

  6 month PFS

Secondary Outcomes (1)

• Overall Survival (OS)

  median OS (up to 2 years)

Study Arms (2)

capecitabine

EXPERIMENTAL

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

Drug: Capecitabine

capecitabine plus mitomycin

EXPERIMENTAL

oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food plus bolus IV infusion Mitomycin 6 mg/m2 day 1

Drug: capecitabine and mitomycin

Interventions

capecitabine and mitomycin DRUG

oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food plus bolus IV infusion mitomycin C 6 mg/m2 day 1. Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months

Also known as: capecitabine, mitomycin

capecitabine plus mitomycin

Capecitabine DRUG

oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food. Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months

capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated IRB/IEC-approved Informed Consent.
• Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the biliary tract (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts).
• Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed).
• Age 18-75 years
• Karnofsky Performance Status \> 50%
• Estimated life expectancy of at least 3 months.
• Negative pregnancy test (if female in reproductive years).
• 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
• 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).
• 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.
• Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol.

You may not qualify if:

• 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.
• Known brain metastases.
• Previous second-line or adjuvant treatment.
• Concurrent treatment with other experimental drugs.
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, cardiac arrhythmia) ≤1 year prior to dosing.
• 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.
• History of interstitial lung disease (eg, pneumonia or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
• Known positive tests for human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C
• Subject who is pregnant or breast feeding
• 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
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Regione Lombardia: collaborator

Study Sites (16)

ASUR zona territoriale N. 6 FABRIANO

Fabriano, Ancona, Italy

Location

Fondazione Istituto San Raffaele G. Giglio

Cefalù, Palermo, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G Salesi

Ancona, Italy

Location

A.O. Ospedali Riuniti

Bergamo, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi

Bologna, Italy

Location

Fondazione Piemontese Per la Ricerca sul Cancro

Candiolo (Torino), 10060, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

Catania, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Istituto Oncologico Veneto I.R.C.C.S.

Padua, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

Azienda Ospedaliera Regionale San Carlo

Potenza, Italy

Location

Istituto Nazionale dei Tumori Regina Elena

Roma, Italy

Location

Ospedale Generale Provinciale

Saronno (VA), Italy

Location

Azienda Ospedaliera Universitaria San Giovanni Battista di Torino

Torino, Italy

Location

Azienda Ospedaliero Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Capecitabine; Mitomycin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• stefano cereda, MD

  Ospedale San Raffaele (Milan, Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 10, 2012
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

IT (16)