Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Panitumumab

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