Clinical trial

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

Name

20020408

Description

The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).

Trial arms

Trial start

2004-01-01

Estimated PCD

2008-10-01

Trial end

2009-06-01

Status

Completed

Phase

Early phase I

Treatment

Best supportive care

Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).

Arms:

Best Supportive Care

Panitumumab

Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.

Arms:

Panitumumab plus best supportive care

Other names:

ABX-EGF

Size

463

Primary endpoint

Progression-free Survival Time

From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.

Eligibility criteria

Inclusion Criteria: * Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy) * Metastatic colorectal carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer * Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen * Unidimensionally measurable disease * Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry * At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer * Adequate hematologic, renal and hepatic function Exclusion Criteria: * Symptomatic brain metastases requiring treatment * History or evidence of interstitial pneumonitis or pulmonary fibrosis * Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment * Prior epidermal growth factor receptor (EGFr) targeting therapies * Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 463, 'type': 'ACTUAL'}}

Updated at

2022-11-07

1 organization

1 product

2 indications

Organization

Product

Indication

Indication