Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

— VANGOGH  

Official title:

A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753675
• Other study ID #: D4200L00007
• Secondary ID: EUDRACT n° 2007-
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: September 27, 2013
• Start date: October 2008
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)

• Patients must have measurable or evaluable but non-measurable disease

• Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).

• WHO performance status 0 to 2: patients must have a WHO PS = 2

Exclusion Criteria:

• Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted

• Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit

• Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of

• History of arrhythmia or QTc with Bazett's correction unmeasurable or = 480 msec on screening ECG

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ampullary Carcinoma
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cancer Of The Extrahepatic Bile Duct
• Carcinoma
• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms
• Liver Neoplasms

Intervention

Drug:
• ZD6474, Vandetanib
300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
• ZD6474, Vandetanib
100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
• Gemcitabine
administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
• Placebo matching ZD6474
Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Locations

Country	Name	City	State
Italy	Research Site	Ancona
Italy	Research Site	Aviano	PN
Italy	Research Site	Brescia	BS
Italy	Research Site	Firenze	FI
Italy	Research Site	Genova	GE
Italy	Research Site	Livorno
Italy	Research Site	Milano	Mi
Italy	Research Site	Napoli
Italy	Research Site	Palermo	PA
Italy	Research Site	Parma	PR
Italy	Research Site	Pisa
Italy	Research Site	Ravenna
Italy	Research Site	Reggio Emilia	RE
Italy	Research Site	Rho
Italy	Research Site	Torino

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JA, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley AL, Hennequin LF. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res. 2002 Aug 15;62(16):4645-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	PFS is calculated from the date of first dose of study medication until the date of objective progression or death (by any cause in the absence of progression). Patients who have not progressed or died at the time of statistical analysis will be censored at the time of their latest objective tumor assessment	up to 1032 days	No
Secondary	Objective Tumor Response Rate (CR+PR),	ORR is the sum of patients with best overall complete or partial responses divided by the patients in the analysis	up to 1032 days	No
Secondary	Disease Control Rate (CR+PR+SD)	DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis	up to 1032 days	No
Secondary	Duration of Response (DOR)	DOR is defined from the date of first documentation of response until date of PD or death	up to 1032 days	No
Secondary	Overall Survivall	OS is defined from the date of randomization to death	up to 1032 days	No