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PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

NCT00911170•Amgen

View on ClinicalTrials.gov

Summary

This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Disease-related:
•Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum
•Locally-advanced or metastatic disease by radiographic evaluation
•Measurable disease
•Has not previously received chemotherapy for locally-advanced or metastatic colorectal cancer. Patient may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent/metastatic disease was documented.
•Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
•Demographic:
•\- Age of 18 years or over
•Laboratory:
•Adequate organ and marrow function as defined below:
+11 more criteria

Exclusion Criteria

•Disease-Related:
•Known brain metastases
•History of another primary malignancy less than/equal to 5 years prior to randomization, with the exception of non-melanoma skin cancer, carcinoma in situ of uterine cervix, and prostatic intraepithelial neoplasia without evidence of prostate cancer
•Prior major surgical procedure less than 28 days prior to day 1 of cycle 1 chemotherapy dosing; anticipated need for major surgical procedure during the 4 cycle treatment period of the study
•Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1 chemotherapy dosing
•Serious nonhealing wound, ulcer, or bone fracture, or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of cycle 1
•Uncontrolled high blood pressure, history of labile hypertension, uncontrolled congestive heart failure, unstable angina within the past 3 months, myocardial infarction or history of stroke within the past 12 months, unstable symptomatic arrhythmia requiring medication, or clinically significant peripheral vascular disease
•History of clinically significant bleeding within 6 months prior to randomization
•History of arterial or venous thromboembolism within 6 months prior to randomization
•History of other disease including uncontrolled diabetes, serious active or uncontrolled infection, metabolic dysfunction; physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the prescribed therapy or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
+13 more criteria

Locations (154)

Research Site

Muscle Shoals, Alabama, United States

Research Site

Jonesboro, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Beverly Hills, California, United States

Research Site

Modesto, California, United States

Research Site

San Diego, California, United States

Research Site

Greenwich, Connecticut, United States

Research Site

Dover, Delaware, United States

Research Site

Gainesville, Florida, United States

Research Site

Loxahatchee Groves, Florida, United States

Key Dates

Start Date

November 3, 2009

Primary Completion Date

September 17, 2012

Completion Date

January 2, 2015

Last Updated

December 29, 2017

Enrollment

847

ACTUAL participants

Conditions

CancerColon CancerColorectal CancerFeverLocally AdvancedMetastatic Colorectal CancerNeutropeniaRectal Cancer

Interventions

Pegfilgrastim

DRUG

Placebo

DRUG

Bevacizumab

BIOLOGICAL

Standard Chemotherapy

DRUG

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RECRUITINGNA

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Breast CancerHigh Risk of Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors