Clinical trial

A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

NCT00819780

Name

20070509

Description

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Trial arms

Trial start

2009-04-24

Estimated PCD

2012-05-30

Trial end

2016-07-07

Status

Completed

Phase

Early phase I

Treatment

Panitumumab

Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).

Arms:

Panitumumab Plus mFOLFOX6

Other names:

Vectibix

Bevacizumab

Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).

Arms:

Bevacizumab Plus mFOLFOX6

Other names:

Avastin

mFOLFOX6

mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m\^2) via ambulatory pump administered for a period of 46 to 48 hours.

Arms:

Bevacizumab Plus mFOLFOX6, Panitumumab Plus mFOLFOX6

Size

285

Primary endpoint

Progression-free Survival (PFS)

From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.

Eligibility criteria

Inclusion Criteria: * Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease * Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines * Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Men or women 18 years of age or older * Adequate hematologic, renal, hepatic, metabolic, and coagulation function Exclusion Criteria: * History of prior or concurrent central nervous system (CNS) metastases * Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma * Clinically significant cardiac disease * Clinically significant peripheral sensory neuropathy * Active inflammatory bowel disease * Recent gastroduodenal ulcer to be active or uncontrolled * History of interstitial lung disease * Recent pulmonary embolism, deep vein thrombosis, or other significant venous event * Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy * Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 285, 'type': 'ACTUAL'}}

Updated at

2022-12-06

1 organization

3 products

3 indications

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Indication

Indication

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