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A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Inclusion Criteria:

- Pathologic diagnosis of metastatic colorectal adenocarcinoma

- A wild-type tumor KRAS gene determined from tumor DNA

- Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan.
Patients may or may not have been treated with bevacizumab.

- Documented disease progression following a treatment with cetuximab in patients who
showed either an objective response after 8 weeks or stable disease after 16 weeks of
cetuximab treatment.

- Age at least 18 years

- ECOG Performance Status 0-2

- Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at
least 9 g/dL

- Bilirubin level less than 1.5 times ULN

- AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence
of liver metastasis)

- Serum creatinine less than 1.5 times ULN

- Effective contraception, if the risk of conception exists

- Life expectancy at least 3 months

- Written informed consent

Exclusion Criteria:

- Symptomatic brain metastasis

- Interstitial pneumonitis or pulmonary fibrosis

- Any other malignancies within 5 years (except for adequately treated carcinoma in
situ of the cervix or non melanoma skin cancer)

- Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks

- Any unstable systemic disease (including active infections, any significant hepatic,
renal or metabolic disease), metabolic dysfunction, physical examination finding, or
clinical laboratory finding that contraindicates the use of study drugs or render the
patient at high risk from treatment complications

- Subject pregnant or breast feeding, or planning to become pregnant within 6 months
after the end of treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of patients alive and without disease progression

Outcome Description:

progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Bruno Daniele, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology


Italy: Ethics Committee

Study ID:




Start Date:

December 2012

Completion Date:

July 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • cetuximab-refractory
  • Colorectal Neoplasms