University of Alabama at Birmingham
This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.
The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis. Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitu…
Inclusion Criteria: 1. Biopsy-confirmed diagnosis of ovarian cancer. 2. Diagnosis of any stage. 3. Diagnosis of any histology. 4. Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following neoadjuvant chemotherapy. 5. Age ≥ 18 years 6. ECOG 1 7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin ≥ 9 gm/dL 2. Absolute Neutrophil Count ≥ 1500 3. White Blood Cell count \> 3000/mm3 4. Platelet coun…
Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection. Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.
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