PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

NCT00115765 | Completed Phase 3 Results

• 1 other identifier: 20040249
• Study Type: interventional
• Target: 1,053
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (Oxaliplatin)

  Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

  Overall study

• Objective Tumor Response Through Week 12 (Irinotecan)

  Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum

  Overall Study

Secondary Outcomes (9)

• Overall Survival (Oxaliplatin)

  Overall study

• Objective Tumor Response Rate (Oxaliplatin)

  Overall study

• Time to Progression (Oxaliplatin)

  Overall Study

• Time to Treatment Failure (Oxaliplatin)

  Overall study

• Overall Survival (Irinotecan)

  Overall study

Study Arms (4)

Oxaliplatin and bevacizumab without panitumumab

ACTIVE COMPARATOR

Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone.

Drug: Oxaliplatin Based Chemotherapy; Drug: Bevacizumab

Irinotecan and bevacizumab plus panitumumab

EXPERIMENTAL

Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Drug: Panitumumab; Drug: Irinotecan Based Chemotherapy; Drug: Bevacizumab

Irinotecan and bevacizumab without panitumumab

ACTIVE COMPARATOR

Irinotecan-based chemotherapy and Bevacizumab Q2W alone

Drug: Irinotecan Based Chemotherapy; Drug: Bevacizumab

Oxaliplatin and bevacizumab plus panitumumab

EXPERIMENTAL

Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Drug: Oxaliplatin Based Chemotherapy; Drug: Panitumumab; Drug: Bevacizumab

Interventions

Oxaliplatin Based Chemotherapy DRUG

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.

Also known as: FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7, Oxaliplatin

Oxaliplatin and bevacizumab plus panitumumab; Oxaliplatin and bevacizumab without panitumumab

Panitumumab DRUG

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.

Also known as: pmab, Vectibix

Irinotecan and bevacizumab plus panitumumab; Oxaliplatin and bevacizumab plus panitumumab

Irinotecan Based Chemotherapy DRUG

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.

Also known as: FOLFIRI, Douillard

Irinotecan and bevacizumab plus panitumumab; Irinotecan and bevacizumab without panitumumab

Bevacizumab DRUG

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 .

Also known as: Avastin

Irinotecan and bevacizumab plus panitumumab; Irinotecan and bevacizumab without panitumumab; Oxaliplatin and bevacizumab plus panitumumab; Oxaliplatin and bevacizumab without panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):672-80. doi: 10.1200/JCO.2008.19.8135. Epub 2008 Dec 29.

  PMID: 19114685 BACKGROUND

• Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.

  PMID: 31378656 DERIVED

• Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.

  PMID: 30679026 DERIVED

Related Links

• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Neoplasms

Interventions

Oxaliplatin; Panitumumab; IFL protocol; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2005
• First Posted: June 27, 2005
• Study Start: June 1, 2005
• Primary Completion: May 31, 2007
• Study Completion: May 1, 2009
• Last Updated: October 17, 2018
• Results First Posted: September 14, 2010

Record last verified: 2018-09