ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Amgen

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Cetuximab; Drug: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001377

ASPECCT

20080763

2009-010715-32 (EudraCT Number)

Details and patient eligibility

About

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 patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

Enrollment: 1,010 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,010 participants in 2 patient groups

Cetuximab

Active Comparator group

Description:

Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.

Treatment:

Drug: Cetuximab

Panitumumab

Experimental group

Description:

Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.

Treatment:

Drug: Panitumumab