ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among subjects with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors...
Brief Summary
Official Title: “A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer”
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among subjects with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2013
Intervention(s) in this Clinical Trial
- Drug: Cetuximab (Erbitux)
- 400 mg/m2 as an initial dose, followed by 250 mg/m2 IV every 7 days
- Drug: Panitumumab (Vectibix)
- 6 mg/kg IV every 14 days
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Cetuximab
- Cetuximab 400 mg/m2 as an initial dose, followed by 250 mg/m2 IV every 7 days
- Experimental: Panitumumab
- Panitumumab (Vectibix) 6 mg/kg IV every 14 days
Outcome Measures for this Clinical Trial
Primary Measures
- To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: No
- Time Frame: 4 years
Secondary Measures
- To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: Yes
- Time Frame: 4 years
- To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: Yes
- Time Frame: 4 years
- To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years.
Safety Issue?: No
- Time Frame: 4 years.
- To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: No
- Time Frame: 4 years
- To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: No
- Time Frame: 4 years
- To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: No
- Time Frame: 4 years
- To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.
- Time Frame: 4 years
Safety Issue?: No
- Time Frame: 4 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
- Wild-type KRAS tumor status
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
- Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
- Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
- Adequate hematologic, renal, hepatic and metabolic function
Exclusion Criteria:
- Symptomatic brain metastases requiring treatment
- Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
- Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
- Clinically significant cardiovascular disease
- Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Amgen Industry
Overall Clinical Trial Officials and Contacts
MD Study Director Amgen
Overall Contact: Amgen Call Center 866-572-6436
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01001377
Study ID Number: 20080763
ClinicalTrials.gov Identifier: NCT01001377
Health Authority: United States: Quorom Institutional Review Board
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01001377
