Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA)

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT00958386
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab+irinotecan — DRUG
    Panitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days. Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab. Each treatment cycle will have a duration of 14 days.

Study Details

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.

Key Dates

Start date
Aug 31, 2009
Status verified
Mar 2015
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Panitumumab+irinotecan

Primary Outcome Measure

Objective response rate [ Time Frame: 2009-2012 ]

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