Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Condition: Colon Cancer; Colorectal Cancer; Rectal Cancer; Cancer; Metastatic Cancer; Metastatic Colorectal Cancer; Oncology
MeSH terms: Colorectal Neoplasms
Intervention: Panitumumab; FOLFIRI
Intervention description: Administered by intravenous infusion; Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: k-ras; biomarker; colorectal; colon; rectal; FOLFOX; FOLFIRI

Summary:

      The primary objective is to estimate the effect of the human homolog of the Kirsten rat
      sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue
      on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving
      second-line chemotherapy with panitumumab after failing first-line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic adenocarcinoma of the colon or rectum

          -  Available paraffin-embedded tumor tissue

          -  Failure of first line treatment containing fluoropyrimidine and oxaliplatin based
             chemotherapy with bevacizumab for mCRC

          -  Measurable disease

          -  Adequate hematologic, renal, hepatic and metabolic function

        Exclusion Criteria:

          -  Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1

          -  Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the
             investigator, precludes the subject from study enrollment

          -  Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or
             vaccine for the treatment of mCRC

          -  CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital,
             carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior
             to Day 1 of Cycle 1

          -  Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of
             Cycle 1

          -  Clinically significant cardiovascular disease

          -  History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)

          -  Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
             8 weeks prior to Day 1 of Cycle 1

          -  Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's
             judgement

          -  Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled
             gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1

          -  Any co-morbid disease or condition that could increase the risk of toxicity (eg,
             dihydropyrimidine deficiency, significant ascites, or pleural effusion)

          -  Major surgery (requiring general anesthesia), open biopsy, or significant traumatic
             injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery
             and have no significant complications