Study of Panitumumab-Capecitabine-Oxaliplatin In Wild-Type K-Ras Metastatic Colorectal Cancer Patients

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients.

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

Details

• Lead Sponsor: Hellenic Cooperative Oncology Group
• Treatments: Antibodies, Monoclonal; Capecitabine; Oxaliplatin; Panitumumab

Criteria

Inclusion Criteria:

1. Ability to comprehend and sign an informed consent

2. Aged 18 years or more

3. Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum

4. Measurable disease according to the RECIST criteria

5. Eastern Cooperative Oncology Group (ECOG) status of 0-2

6. Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)

7. Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L

8. Renal function: serum creatinine ≤1.5xUNL or creatinine clearance > 50ml/min

9. Hepatic function:

• Total bilirubin ≤ 1.5 time the upper normal limit (UNL)

• ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases

• ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases

10. Metabolic function:

• Magnesium ≥ lower limit of normal.

• Calcium ≥ lower limit of normal.

Exclusion Criteria:

1. Central nervous system metastases

2. Prior therapy for metastatic disease

3. Adjuvant chemotherapy for the last 6 months

4. Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors

5. Prior radiotherapy within 30 days from enrollment

6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment

7. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

8. Inflammatory bowel disease or chronic diarrhea

9. Dihydropyrimidine deficiency

10. Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection

11. Any kind of disorder compromising the ability of the patient to give informed consent

12. Any investigational agent within 30 days prior to initiation of the study

13. Any surgical procedure within 28 days prior to initiation of the study

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

15. Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.

16. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.