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Comparison of Survival Benefi...

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Last Updated: 2017-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panitumumab + BSC

Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug.

Group Type EXPERIMENTAL

Best Supportive Care (BSC)

Intervention Type OTHER

BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.

Panitumumab

Intervention Type DRUG

Administered intravenously

BSC Alone

Participants received best supportive care until disease progression, withdrawal of consent, or death.

Group Type OTHER

Best Supportive Care (BSC)

Intervention Type OTHER

Interventions

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Best Supportive Care (BSC)

Intervention Type OTHER

Panitumumab

Administered intravenously

Intervention Type DRUG

Other Intervention Names

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Vectibix

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of metastatic colorectal cancer (CRC)
* Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
* Treatment failure (defined as failure due to either disease progression \[clinical or radiological\] or toxicity \[treatment intolerance\]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.

* Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
* Man or woman at least 18 years of age
* Adequate hematologic, renal, hepatic and metabolic function
* Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
* Subject or subject's legally acceptable representative has provided informed consent.
* Other protocol-specified criteria may apply

Exclusion Criteria

* Symptomatic brain metastases requiring treatment
* History of another primary cancer within 5 years of randomization
* 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) within 21 days before randomization
* Radiotherapy within 14 days before randomization.
* Other protocol-specified criteria may apply

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers