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A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer


Inclusion Criteria:



- Man or woman at least 18 years old

- Diagnosis of metastatic colorectal cancer

- At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST

- ECOG performance status of 0, 1, or 2

- Paraffin-embedded tumor tissue from the primary tumor or metastasis available for
central analyse Exclusion Criteria:

- History or known presence of CNS metastases

- History of another primary cancer, except: Curatively treated in situ cervical
cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid
tumor curatively treated with no known active disease present and no treatment
administered for ≥ 5 years before randomization

- Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal
carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior
fluoropyrimidine therapy administered solely for the purpose of radiosensitization

- Prior oxaliplatin therapy

- Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule
EGFr inhibitors (eg, erlotinib)

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg,
pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on
baseline chest CT scan

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as > CTC grade 2 [CTCAE version 3.0])

- Peripheral sensory neuropathy with functional impairment

Type of Study:

Interventional

Study Design:

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

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

20050203

NCT ID:

NCT00364013

Start Date:

July 2006

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Oncology
  • Cancer
  • metastatic colorectal cancer
  • EGFr
  • Panitumumab
  • Clinical Trail
  • Amgen
  • Colorectal Neoplasms

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