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Anti-metabolites

Treatment (panitumumab, combination chemotherapy) for Rectal Cancer

Phase 2
Waitlist Available
Led By John Hays, MD
Research Sponsored by John Hays
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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

Eligible Conditions
  • Rectal Cancer
  • Adenocarcinoma of the Colon
  • Colon Cancer
  • Adenocarcinoma of the Rectum
  • Colorectal Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival(PFS)
Secondary study objectives
Frequency and severity of toxicities of the regimens, graded according to the NCI CTCAE v4.0
Overall survival

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (panitumumab, combination chemotherapy)Experimental Treatment4 Interventions
5-Fluorouracil, irinotecan, and panitumumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
FDA approved
Irinotecan
FDA approved
Fluorouracil
FDA approved
Leucovorin
FDA approved

Find a Location

Who is running the clinical trial?

John HaysLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
AmgenIndustry Sponsor
1,431 Previous Clinical Trials
1,385,180 Total Patients Enrolled
John Hays, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
56 Total Patients Enrolled
~1 spots leftby Nov 2025
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