Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115765
Recruitment Status : Completed
First Posted : June 27, 2005
Results First Posted : September 14, 2010
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin Based Chemotherapy Drug: Panitumumab Drug: Irinotecan Based Chemotherapy Drug: Bevacizumab Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1053 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
Actual Study Start Date : June 1, 2005
Actual Primary Completion Date : May 31, 2007
Actual Study Completion Date : May 1, 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Oxaliplatin and bevacizumab without panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone.
 Drug: Oxaliplatin Based Chemotherapy
Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
Other Names:
  • FOLFOX 4
  • FOLFOX 5
  • Modified FOLFOX 6
  • FOLFOX 7
  • Oxaliplatin

Drug: Bevacizumab
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
Other Name: Avastin
Experimental: Irinotecan and bevacizumab plus panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W
 Drug: Panitumumab
PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
Other Names:
  • pmab
  • Vectibix

Drug: Irinotecan Based Chemotherapy
Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
Other Names:
  • FOLFIRI
  • Douillard

Drug: Bevacizumab
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
Other Name: Avastin
Active Comparator: Irinotecan and bevacizumab without panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W alone
 Drug: Irinotecan Based Chemotherapy
Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
Other Names:
  • FOLFIRI
  • Douillard

Drug: Bevacizumab
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
Other Name: Avastin
Experimental: Oxaliplatin and bevacizumab plus panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W
 Drug: Oxaliplatin Based Chemotherapy
Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
Other Names:
  • FOLFOX 4
  • FOLFOX 5
  • Modified FOLFOX 6
  • FOLFOX 7
  • Oxaliplatin

Drug: Panitumumab
PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
Other Names:
  • pmab
  • Vectibix

Drug: Bevacizumab
Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
Other Name: Avastin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-Free Survival (Oxaliplatin) [ Time Frame: Overall study ]
    Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

  2. Objective Tumor Response Through Week 12 (Irinotecan) [ Time Frame: Overall Study ]
    Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum


Secondary Outcome Measures :
  1. Overall Survival (Oxaliplatin) [ Time Frame: Overall study ]
    Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin

  2. Objective Tumor Response Rate (Oxaliplatin) [ Time Frame: Overall study ]
    Best overall response of complete or partial response within oxaliplatin stratum

  3. Time to Progression (Oxaliplatin) [ Time Frame: Overall Study ]
    Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum

  4. Time to Treatment Failure (Oxaliplatin) [ Time Frame: Overall study ]
    Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.

  5. Overall Survival (Irinotecan) [ Time Frame: Overall study ]
    Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.

  6. Progression-free Survival (Irinotecan) [ Time Frame: Overall Study ]
    Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

  7. Objective Tumor Response Rate (Irinotecan) [ Time Frame: Overall Study ]
    Best overall response of complete or partial response within irinotecan stratum

  8. Time to Progression (Irinotecan) [ Time Frame: Overall Study ]
    Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum

  9. Time to Treatment Failure (Irinotecan) [ Time Frame: Overall Study ]
    Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the colon or rectum
  • Metastatic colorectal cancer (mCRC)
  • Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria
  • ECOG performance status of 0 or 1
  • Available paraffin-embedded tumor tissue (from primary tumor or metastasis) or unstained slides of paraffin-embedded tissue

  • If history of other primary cancer, subject will be eligible only if she or he has:

    • Curatively resected non-melanomatous skin cancer;
    • Curatively treated cervical carcinoma in situ;
    • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 5 years.

  • Adequate hematologic data as follows:

    • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 cells/L;
    • Platelet count greater than or equal to 100 x 10^9/L;
    • Hemoglobin greater than or equal to 9.0 g/dL. - Adequate renal function:
    • Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN);
    • Urinary protein dipstick of less than 2+ (if urinary dipstick 2+ or greater, then excretion of less than or equal to 1000 mg of protein per day as determined by 24-hour urine collection).

  • Adequate hepatic function:

    • Alkaline phosphatase less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
    • Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)(AST) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
    • Alanine aminotransferase (serum glutamic-pyruvic transaminase) (ALT) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
    • Bilirubin less than or equal to 2 x ULN. - Competent to comprehend, sign, and date an IRB-approved informed consent form
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

  • Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
  • Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
  • Major surgery within 28 days before randomization
  • Central nervous system metastases
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
  • Clinically significant ascites
  • Preexisting bleeding diathesis or coagulopathy or the need for full-dose anticoagulation

  • Any of the following within 1 year before randomization:

    • Myocardial infarction;
    • Unstable angina;
    • Symptomatic congestive heart failure;
    • Serious uncontrolled cardiac arrhythmia;
    • Cerebrovascular accident or transient ischemic attack;
    • Gastrointestinal ulcer or hemorrhage;
    • Hemoptysis;
    • Pulmonary embolism;
    • Deep vein thrombosis, or other significant thromboembolic event.
  • Regular use of non-steroidal anti-inflammatory agents
  • Female subject of childbearing potential, not abstinent, and not willing to use contraceptives during the course of the study and for 6 months following the last dose of first-line treatment
  • Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
  • Male subject, not abstinent, and not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of first-line treatment
  • Subject known to be human immunodeficiency virus (HIV) positive
  • Subject allergic to panitumumab or any components of panitumumab formulation
  • History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
  • Subject unwilling or unable to comply with study requirements
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115765


Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00115765    
Other Study ID Numbers: 20040249
First Posted: June 27, 2005    Key Record Dates
Results First Posted: September 14, 2010
Last Update Posted: October 17, 2018
Last Verified: September 2018
Keywords provided by Amgen:
Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study)
Colorectal, Colon, Rectal Cancer, Metastatic Colorectal
Cancer
EGFr, Clinical Trial
 Panitumumab, ABX-EGF
Immunex, Abgenix, Amgen
Metastatic Colorectal Cancer
Oncology
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Panitumumab
 Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action