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Sponsors and Collaborators: |
University College, London AstraZeneca |
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Information provided by: | University College, London |
ClinicalTrials.gov Identifier: | NCT00939848 |
As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely to become the international standard of care for patients with advanced biliary tract cancer (submitted: ASCO 2009).
This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease progression in this patient group.
Condition | Intervention | Phase |
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Biliary Tract Neoplasms |
Drug: gemcitabine Drug: cisplatin Drug: Placebo Drug: cediranib |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Phase II/III Study of Cediranib (AZD2171) or Placebo in Combination With Cisplatin/Gemcitabine for Patients With Advanced Biliary Tract Cancers |
Estimated Enrollment: | 136 |
Study Start Date: | December 2009 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental
The experimental arm will consist of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle with cediranib 20mg oral daily (continuous dosing).
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Drug: cisplatin
cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
Drug: cediranib
cediranib 20mg oral daily (continuous dosing)until evidence of disease progression has been confirmed
Drug: gemcitabine
gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
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Arm A: Placebo Comparator
The control arm will consist of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle with a matching placebo 20mg od (continuous dosing)
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Drug: gemcitabine
gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
Drug: cisplatin
cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
Drug: Placebo
20mg od (continuous dosing) until evidence of disease progression has been confirmed
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Although there is currently no standard chemotherapy for patients with advanced biliary tract cancers (ABC) the UK ABC-02 study (the largest study by far in this patient group, n=410) is likely to define CisGem as the global standard of care for this disease based on a significantly improved progression-free survival and overall survival compared to gemcitabine alone.
Vascular endothelial growth factor (VEGF) is a pivotal stimulus of physiologic and pathologic angiogenesis, including the sustained neo-vascularisation required to support solid tumour growth. Human biliary tract carcinoma cells have higher expression of VEGF both in cell lines and tissues (detected in 75.6% of 33 resected clinical specimens) and this is associated with significantly higher levels of microvessel density and the presence of intrahepatic metastases. Cediranib is a highly potent inhibitor of VEGF receptor 2 tyrosine kinase and VEGF-induced signalling in endothelial cells. It has been safely combined with a CisGem regimen in lung cancer patients.
Aims This trial aims to evaluate the effect on progression-free survival of cediranib in combination with CisGem chemotherapy compared to CisGem and placebo.
Summary of study Consenting patients with ABC (inoperable, locally advanced, recurrent or metastatic) will receive CisGem chemotherapy and either cediranib (experimental arm) or placebo (standard arm) orally. Treatment will continue until disease progression (chemotherapy will stop at 24 weeks) with tumour reassessment by CT/MRI scans at 12-weekly intervals. All patients will be followed up for survival analysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon K Hughes, BSc | +44(0)2076799688 ext . | s.hughes@ctc.ucl.ac.uk |
Contact: Wendy Wood, PhD | +44(0)2076799858 | w.wood@ctc.ucl.ac.uk |
Principal Investigator: | Juan Valle, MD | Christie Hospital NHS Foundation Trust |
Responsible Party: | University College London (Joint UCLH & UCL Biomedical Research Unit) ( Nick Mc Nally ) |
Study ID Numbers: | ABC-03 09/0193 |
Study First Received: | July 14, 2009 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00939848 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Disease-Free Survival |
Antimetabolites Anti-Infective Agents Biliary Tract Neoplasms Digestive System Neoplasms Immunologic Factors Antiviral Agents Immunosuppressive Agents |
Digestive System Diseases Cisplatin Radiation-Sensitizing Agents Biliary Tract Diseases Gastrointestinal Neoplasms Biliary Tract Cancer Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Biliary Tract Neoplasms Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Cisplatin Radiation-Sensitizing Agents Biliary Tract Diseases Therapeutic Uses Gemcitabine |