NCT01260415

A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases

A Phase II Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to assess whether treatment with chemotherapy drugs FOLFOX (5-Fluorouracil (5FU), Oxaliplatin (Eloxatin) and Leucovorin (Folinic Acid)) or FOLFIRI (5-Fluorouracil (5FU), Irinotecan (Camptosar) and Leucovorin (Folinic Acid))and panitumumab before and after surgery can improve outcome in patients with liver metastases (the cancer has spread to other parts of the body such as the liver) that are resectable (can be surgically removed), from colorectal cancer that have a non mutant (wild-type) K-ras gene. FOLFOX/FOLFIRI is an intravenous (given by vein) chemotherapy combination that is approved for colorectal cancer while panitumumab is also an intravenous drug and have been approved for treatment of refractory (not responding treatment) metastatic colorectal cancer whose cancers have the K-ras gene. These drugs are not approved for the treatment of colorectal cancer liver metastases (CRCLM) who can have surgery. Patients will receive FOLFOX/FOLFIRI and panitumumab for four 2-week cycles before surgery. Surgery will be done no sooner than 4 weeks and no later than 8 weeks, after completion of the fourth cycle of chemotherapy. If the liver metastases after the chemotherapy and surgery decreases or stops growing, then chemotherapy will be given after surgery. Treatments will start no sooner than 4 weeks, and no later than 12 weeks, after surgery. Patients will receive a maximum of 8 cycles of treatment with the combination of drugs and then receive panitumumab alone for a maximum of 12 cycles. On treatment visits, patients will also have tests and procedures done. As part of the study, patients will provide archival tumor tissue and sample of tissue removed from surgery for K-ras testing. Patients will also be given the option of allowing the collected tissue for research (biomarker) studies and banking for future studies.

Detailed description

Emerging data suggests that KRAS mutation is a strong predictor for resistance to EGFR antagonist therapy. In the KRAS wild-type cohort, the addition of EGFR antagonists to chemotherapy has been shown to improve RR and PFS. Improved response rate to neoadjuvant chemotherapy would be expected to improve surgical outcomes for patients with CRCLM. We therefore wish to test the hypothesis that the combination of FOLFOX/FOLFIRI and panitumumab, given perioperatively to patients with wild-type KRAS CRCLM will improve outcome, compared to historical control, in optimally resectable patients. As this patient population remains at high risk for recurrence post-chemotherapy, we also wish to explore the tolerability and efficacy of continued panitumumab monotherapy for an additional 6 months. As opposed to most clinical trials for advanced colorectal cancer where the majority are treated with palliative intent, patients in this trial will all be treated aggressively with curative intent at the outset. There is also the additional benefit of assessment of tumor tissue after treatment with a biologic agent.

Conditions

• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Panitumumab, Oxaliplatin, 5-FU	* Panitumumab 6 mg / kg, given over 60 minutes * Oxaliplatin 85 mg / m2 combined with leucovorin 400 mg / m2, given over 2 hours OR * Irinotecan 180 mg / m2 , given over 90 minutes, concurrent with leucovorin 400 mg / m2, given over 90 minutes * 5FU 400 mg / m2, by bolus infusion * 5FU 2400 mg / m2, given over 46 hours

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-12-15
• Last updated: 2019-05-14

Locations

4 sites across 1 country: Canada