Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Collaborator: Amgen
• Treatments: Antibodies, Monoclonal; Camptothecin; Irinotecan; Panitumumab

Criteria

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 rectum.

• 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 criteria.

• 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 g/dL

• 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 arrhythmia

• 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