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An Open-label Randomized Phase II Study of Panitumumab Plus Oral Capecitabine and Infusional Oxaliplatin (XELOX) or XELOX Alone for Second-line Treatment of Patients With Metastatic Colorectal Cancer (VOXEL-Study)

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

An Open-label Randomized Phase II Study of Panitumumab Plus Oral Capecitabine and Infusional Oxaliplatin (XELOX) or XELOX Alone for Second-line Treatment of Patients With Metastatic Colorectal Cancer (VOXEL-Study)

Subjects with metastatic colorectal cancer with KRAS-wildtype will be randomized in a 1:1
ratio to receive a 2nd line treatment regimen of panitumumab plus oxaliplatin and
capecitabine (XELOX) or XELOX alone. Before randomization tumour of all subjects will be
analyzed to detect the KRAS mutational status. Subjects will only be randomized into these
two arms if the tumour shows KRAS wild-type. Subjects with KRAS mutant colorectal tumours
will receive XELOX alone. Subjects will receive treatment cycles every three weeks.
Treatment will continue until subjects are diagnosed with disease progression or intolerable
toxicity, at which time the subjects will be withdrawn from the treatment phase. If a
subject withdraws from chemotherapy due to toxicity the subjects will be allowed to continue
with panitumumab monotherapy with or without one of the chemotherapy components until
disease progression. After withdrawing panitumumab and XELOX treatment, all subjects will
end the treatment phase and will enter a follow-up phase until 6 months after the last
patient stopped treatment (with a safety follow-up visit after 56 days ± 3 days and long
term follow-up visits every 12 weeks). During the treatment phase subjects will be evaluated
for tumour response every 9 weeks (± one week) through to week 45, and every 12 weeks (± two
weeks) thereafter, until disease progression. Subjects with symptoms suggestive of disease
progression should be evaluated for tumour response at the time symptoms occur.

Inclusion Criteria:

- Male or female patients aged 18 years or more, with histologically or
cytologically-confirmed and radiologically-measurable metastatic colorectal cancer.

- One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and
irinotecan based chemotherapy. Subjects must have disease progression (as assessed by
the investigator) and must be no candidates for primary metastasectomy.

- Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have
been evaluated within 28 days prior to registration / randomization, and diagnosed by
the investigator.

- Liver and kidney function within defined ranges and sufficient bone marrow reserve.

Exclusion Criteria:

- Central nervous system metastases, or significant cardiovascular disease.

- Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule
EGFR tyrosine kinase inhibitors (e.g. erlotinib).

- Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with
oxaliplatin based combination for non-metastatic disease is allowed if terminated > 6
months prior to initiation of screening and without progression during the treatment
with oxaliplatin.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Ralf Grunewald, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gemeinschaftspraxis Hämatologie / Onkologie Im Prüfling 17-19 60389 Frankfurt


Germany: Paul-Ehrlich-Institut

Study ID:

AIO KRK 0107



Start Date:

September 2009

Completion Date:

March 2012

Related Keywords:

  • Colorectal Neoplasms
  • Open-label
  • Phase-II-Study
  • Randomized
  • Metastatic
  • Colorectal
  • Cancer
  • Panitumumab
  • Vectibix®
  • second-line-treatment
  • KRAS
  • Neoplasms
  • Colorectal Neoplasms