Clinical Trial: Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Panitumumab in Combination With FOLFIRI After Progression on FOLFIRI Plus Bevacizumab in KRAS(Kirsten Rat Sarcoma) and NRAS Wild-Type Metastatic Colorectal Cancer.

Brief Summary: This phase II trial studies how well panitumumab and combination chemotherapy works in treating patients with metastatic colorectal cancer previously treated with combination chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab and combination chemotherapy together may kill more tumor cells

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the median progression-free survival in patients treated with leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and panitumumab for K-ras and NRAS wild-type, metastatic colorectal carcinoma who have already progressed on FOLFIRI + Bevacizumab.

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of toxicities of the regimens. II. To determine overall response rate. III. To determine the median overall survival and the overall survival rate at 1 year.

OUTLINE:

Patients receive panitumumab intravenously (IV) over 60-90 minutes, leucovorin calcium IV over 90 minutes, fluorouracil IV continuously over 46 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.


Sponsor: Kristen Ciombor

Current Primary Outcome: Progression free survival(PFS) [ Time Frame: Time from study day 1 to the time the patient is first recorded as having disease progression or death, assessed up to 2 years ]

Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Estimated using the Kaplan-Meier estimator with confidence interval calculated based on the Brookmeyer-Crowley method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency and severity of toxicities of the regimens, graded according to the NCI CTCAE v4.0 [ Time Frame: Up to 2 years ]
    Frequencies will be computed for discrete data.
  • Overall response rate, as described in RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
  • Overall survival [ Time Frame: Time from study day 1 to the date of death or the last date the patient was known to be alive, assessed up to 1 year ]
    Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Kaplan-Meier estimator will be used.


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: February 25, 2013
Date Started: February 2013
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016