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

Roche

Status and phase

Completed

Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]

Drug: erlotinib [Tarceva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00925769

2008-004444-36

ML20784

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.