Irinotecan With or Without Panitumumab or Cyclosporine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Fluorouracil
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|ClinicalTrials.gov Identifier: NCT00389870|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 19, 2006
Last Update Posted : August 26, 2013
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclosporine may help irinotecan work better by making tumor cells more sensitive to the drug. 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. Panitumumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether irinotecan is more effective when given with or without panitumumab or cyclosporine in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying irinotecan to compare how well it works when given with or without panitumumab or cyclosporine in treating patients with advanced or metastatic colorectal cancer that did not respond to fluorouracil.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: panitumumab Drug: cyclosporine Drug: irinotecan hydrochloride||Phase 3|
- Compare the efficacy and toxicity of single-agent irinotecan hydrochloride (Ir) vs Ir with cyclosporine (IrC) in patients with fluorouracil-resistant advanced colorectal cancer.
- Compare the efficacy of single-agent Ir vs Ir with panitumumab (IrP) in these patients.
- Correlate the toxicity of Ir and/or IrC with genetic variability in the enzymes involved in irinotecan hydrochloride's disposition pathway.
- Compare IrC to Ir and its metabolites (SN38; SN38G), in terms of pharmacokinetic profile.
- Correlate the benefit of IrP with tumor expression of epidermal growth factor receptor (EGFR) or its known down-stream molecules as a predictive measure.
- Correlate IrP efficacy or toxicity (specifically the severity of skin rash) with somatic alterations in the EGFR gene and/or with germline variability in related genes.
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to prior cetuximab (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive irinotecan hydrochloride IV over 30-90 minutes on day 1.
- Arm II: Patients receive irinotecan hydrochloride IV over 15-40 minutes on day 1 and oral cyclosporine three times a day on days 1-3.
- Arm III: Patients receive panitumumab IV over 30-90 minutes followed by irinotecan hydrochloride IV over 30-90 minutes on day 1. Single-agent panitumumab may be continued during breaks in chemotherapy treatment.
In all arms, treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 12 and 24 weeks.
After completion of study treatment, patients are followed every 12 weeks for 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,269 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1269 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Clinical Trial of Treatment for Fluorouracil-Resistant Advanced Colorectal Cancer Comparing Standard Single-Agent Irinotecan Versus Irinotecan Plus Panitumumab and Versus Irinotecan Plus Ciclosporin [Panitumumab, Irinotecan & Ciclosporin in COLOrectal Cancer Therapy (PICCOLO)]|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||March 2010|
- Proportion of patients treated with irinotecan hydrochloride (Ir) alone vs Ir and cyclosporine (IrC) who are progression-free at 12 weeks
- Overall survival of patients treated with Ir vs Ir and panitumumab (IrP) and no prior cetuximab
- Proportion of patients free from treatment failure at 12 weeks in patients treated with Ir vs IrC
- Overall survival in patients treated with Ir vs IrC
- Nurse-assessed toxicity (all-cause mortality, diarrhea ≥ grade 3 at 12 weeks) in patients treated with Ir vs IrC
- Progression-free at 12 weeks in patients treated with Ir vs IrP and no prior cetuximab
- Nurse assessed toxicity (all-cause mortality) in patients treated with Ir vs IrP and no prior cetuximab
- Progression-free survival in patients treated with Ir vs IrP and prior cetuximab
- Best response at 1 year in patients treated with Ir vs IrP and prior cetuximab
- Patient-assessed symptom/quality of life/acceptability scores at 12 and 24 weeks in patients treated with Ir vs IrP and prior cetuximab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389870
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|Study Chair:||Matthew T. Seymour, MA, MD, FRCP||Cookridge Hospital|