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ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00925769
First received: April 15, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Pancreatic Cancer
 Drug: bevacizumab [Avastin]
Drug: erlotinib [Tarceva]
Drug: capecitabine [Xeloda]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety and Effect on Disease Progression of Triple Combination Treatment With Erlotinib (Tarceva), Bevacizumab (Avastin), and Capecitabine (Xeloda) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer (REBECA-Trial).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events, laboratory parameters (Part 1) [ Time Frame: on days 1-8 of 1st 2-week cycle and on days 1 and 8 of every following cycle ] [ Designated as safety issue: No ]
  • Freedom from progression (Part 2) [ Time Frame: Event driven--monitored at 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control rate, clinical benefit response rate, overall survival (Part 2) [ Time Frame: Event driven--monitored at 3 and 6 months ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters (Part 2) [ Time Frame: on days 1 and 8 of every 2-week cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
Escalating doses of 5/10mg/kg q2w
Drug: erlotinib [Tarceva]
Escalating doses of 100/150mg daily
Drug: capecitabine [Xeloda]
Escalating doses of 500/650/750/900mg/m2 bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • pancreatic cancer with locally advanced and/or metastatic disease (stage IV);
  • chemonaive for metastatic or locally advanced disease;
  • ECOG performance status of 0-2.

Exclusion Criteria:

  • local (stage IA to IIB)and locally advanced (stage III) pancreatic cancer;
  • previous exposure to Avastin, Tarceva or Xeloda;
  • other primary tumor within the last 5 years prior to enrollment, except for adequately treated cancer in situ of cervix, or basal cell skin cancer;
  • current or recent chronic use of aspirin (>325 mg/day) or full therapeutic dose of anticoagulants or thrombolytic agents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925769

Contacts
Contact: Please reference Study ID Number: ML20784 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Austria
Recruiting
Wien, Austria, 1100
Recruiting
Wien, Austria, 1130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00925769     History of Changes
Other Study ID Numbers: ML20784, 2008-004444-36
Study First Received: April 15, 2009
Last Updated: May 7, 2013
Health Authority: Austria:BASG

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Bevacizumab
Erlotinib
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013