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

Sponsor
Hoffmann-La Roche
Study ID
NCT00925769
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    Escalating doses of 5/10mg/kg q2w
  • capecitabine [Xeloda] — DRUG
    Escalating doses of 500/650/750/900mg/m2 bid
  • erlotinib [Tarceva] — DRUG
    Escalating doses of 100/150mg daily

Study Details

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.

Key Dates

First listed
Jun 22, 2009
Start date
Jan 31, 2009
Status verified
Jul 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Part 1: Maximum Tolerated Dose (MTD) of Capecitabine [ Time Frame: Up to Week 6 (Cycle 1-3) ]

Related Studies