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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00925769
First received: April 15, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 2 part study will evaluate the safety and efficacy of a combination of Avas tin, 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, co horts of patients will receive escalating doses of combination treatment to dete rmine the maximum tolerated dose. The recommended dose will be used in the secon d 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: capecitabine [Xeloda]
Drug: erlotinib [Tarceva]
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:


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 ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: December 2013
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: capecitabine [Xeloda]
Escalating doses of 500/650/750/900mg/m2 bid
Drug: erlotinib [Tarceva]
Escalating doses of 100/150mg daily

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925769

Locations
Austria
Vienna, Austria, 1100
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: August 26, 2014
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 August 28, 2014