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A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer

Aside from limited cases of resectable metastatic disease, mCRC cannot be cured with the
currently available chemotherapy regimens, and there is a continued need to improve the
current treatment.

Panitumumab has demonstrated objective tumour response, increase in progression free
survival and has an acceptable safety profile in clinical studies in patients with
metastatic colorectal cancer when used as a monotherapy or in combination with irinotecan
(Meropol et al, 2003; Berlin et al, 2004; Hecht et al, 2004; Malik et al, 2005).

The addition of panitumumab to chemotherapy is expected to enhance the treatment effect of

This is a Phase II, single-arm, multi-centre study. Eligible subjects will be enrolled and
treated with second-line combination therapy consisting of panitumumab and irinotecan.

Prior to study entry and in order to confirm eligibility, the investigator or designee will
review existing radiological images in addition to any other relevant clinical documents
(reports, notes, etc.) to ensure the subject has failed or relapsed while on or after one
prior chemotherapy regimen.

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg once Q3W.
Irinotecan chemotherapy (350 mg/m2) will be administered after the administration of
panitumumab. Subjects will be permitted to receive panitumumab and chemotherapy until he or
she develops disease progression (PD) or experiences unacceptable toxicities. Subjects who
discontinue irinotecan, for example due to toxicity, will be permitted to receive
panitumumab monotherapy. After discontinuation of panitumumab, the treatment period will end
and subjects will attend a safety follow-up visit 56 ±3 days later.

Tumour response assessment will be performed by the investigator per the modified Response
Evaluation Criteria in Solid Tumours (m-RECIST). Subjects will be evaluated for tumour
response every 9 weeks ± 1 week until PD or withdrawal from the trial. Responding disease
will be confirmed no less than 28 days after the criteria for response are first met.
Subjects with symptoms suggestive of PD should be evaluated for tumour progression at the
time the symptoms occur.

Subjects will complete an EQ-5D PRO questionnaire every 6 weeks ± 1 week, from baseline
through to the end of the treatment period and at the safety follow-up visit.

Inclusion Criteria:

- Man or woman > 18 years of age

- Competent to comprehend, sign, and date an IEC-approved informed consent form

- Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or

- Radiographically documented disease progression per modified RECIST criteria either
while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy
for mCRC

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

- If subject has prior history of cancer other than colorectal carcinoma, basal cell
carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or
active disease within 5 years.

- Prior radiotherapy is acceptable.

- One and only one prior chemotherapy regimen for mCRC consisting of first-line
fluoropyrimidine-based chemotherapy.

- ECOG performance status of 0, 1 or 2

- Life expectancy ≥ 3 months

- Hematologic function:ANC > 1.5 x 109/L, Platelet count > 100 x 109/L, Hemoglobin > 10

- Renal function: Creatinine < 1.5 mg/dL

- Hepatic function: AST and ALT < 3 x ULN (if liver metastases < 5 x ULN)

- Bilirubin < 2 x ULN

Exclusion Criteria:

- No more than one prior chemotherapy regimen for mCRC consisting of first-line
fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based
chemotherapy is allowed)

- Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the
exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months
prior to enrolment.

- Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved
proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion

- Unresolved toxicities from prior systemic therapy that, in the opinion of the
investigator, does not qualify the patient for inclusion

- Central nervous system/brain metastases

- Significant cardiovascular disease including unstable angina or myocardial infarction
within 6 months before initiating study treatment or a history of ventricular

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

- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
pneumonitis or pulmonary fibrosis on baseline chest CT scan

- Treatment for systemic infection within 14 days before initiating study treatment

- Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all
radiotherapy-related toxicities

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
(defined as > 4 loose stools per day)

- History of Gilbert's syndrome or dihydropyrimidine deficiency

- History of any medical condition that may increase the risks associated with study
participation or may interfere with the interpretation of the study results

- Known positive test for human immunodeficiency virus infection, hepatitis C virus,
chronic active hepatitis B infection

- subject allergic to the ingredients of the study medication or to Staphylococcus
protein A

- Any co-morbid disease that would increase risk of toxicity

- Any kind of disorder that compromises the ability of the subject to give written
informed consent and/or comply with the study procedures

- Any investigational agent within 30 days before enrolment

- Must not have had a major surgical procedure within 28 days of randomization

- Subject who is pregnant or breast feeding

- Woman or man of childbearing potential not consenting to use adequate contraceptive
precautions i.e. double barrier contraceptive methods

- Subject unwilling or unable to comply with study requirements

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Alfredo Carrato, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Cooperative Group for Gastrointestinal Tumour Therapy


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

May 2007

Completion Date:

March 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic colorectal cancer
  • 2nd-line Therapy
  • panitumumab
  • irinotecan
  • Colorectal Neoplasms