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Trial record 58 of 168 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

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: NCT01226719
Recruitment Status : Completed
First Posted : October 22, 2010
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Panitumumab
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Leucovorin
Drug: 5-Fluorouracil
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Period Title: Overall Study
Started 15
Completed 2 [1]
Not Completed 13
[1]
Completed = patient is surgical candidate, underwent resection, received treatment to week 24.
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
All patients on study
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
55
(39 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients deemed to be evaluable for response who were evaluated for response
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description:

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of evaluable participants
75
2.Secondary Outcome
Title R0 Resection Rate
Hide Description To determine the rate of complete (R0) resection for patients treated with this regimen.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were surgical candidates and underwent surgery on study
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description:

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of patients with surgery
100
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on study
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description:

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
13.3 [1] 
(4.2 to NA)
[1]
Upper bound of 95% confidence interval not reached at this time
4.Secondary Outcome
Title To Determine the Acute Toxicity Produced by This Regimen.
Hide Description The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on study
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description:

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Rash 12
Diarrhea 9
Fatigue 8
Nausea 8
Mucositis 7
Peripheral neuropathy 6
Vomiting 5
Anorexia 4
Cold sensitivity 4
Constipation 4
Dehydration 4
Leukopenia 4
Anemia 3
Hypokalemia 3
Hypomagnesemia 3
Nail changes 3
Neutropenia 3
Taste alteration 3
Thrombocytopenia 3
Weight loss 3
Abdominal pain 2
Alopecia 2
Depression 2
Dizziness 2
Insomnia 2
Alkaline phosphatase increased 1
ALT increased 1
Anxiety 1
AST increased 1
Asthenia 1
Back pain 1
Blood bicarbonate increased 1
Decreased ejection fraction 1
Dry mouth 1
Dysesthesia 1
Dyspepsia 1
Edema 1
Epistaxis 1
Flashers 1
Hand-foot syndrome 1
Hematochezia 1
Hemorrhoids 1
Hyperpigmentation 1
Hypertension 1
Hypoalbuminemia 1
Hyponatremia 1
Infection - other 1
Infusion related reaction 1
Memory loss 1
Oral infection 1
Paraphasia 1
Pruritus 1
Speech impairment 1
Swollen tongue 1
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on study
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description:

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median overall survival and 95% confidence interval not reached at this time point - biostaticians are not reporting the lower bound of the 95% confidence interval when median overall survivial cannot be calculated
Time Frame 18 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOLFOXIRI+Panitumumab Regimen
Hide Arm/Group Description

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

All-Cause Mortality
FOLFOXIRI+Panitumumab Regimen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FOLFOXIRI+Panitumumab Regimen
Affected / at Risk (%)
Total   2/15 (13.33%) 
Gastrointestinal disorders   
Diarrhea  1  2/15 (13.33%) 
Mucositis  1  1/15 (6.67%) 
Nausea  1  1/15 (6.67%) 
Vomiting  1  1/15 (6.67%) 
General disorders   
Fatigue  1  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFOXIRI+Panitumumab Regimen
Affected / at Risk (%)
Total   15/15 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  3/15 (20.00%) 
Eye disorders   
Blurred vision  1  1/15 (6.67%) 
Conjunctivitis  1  1/15 (6.67%) 
Dry eye  1  1/15 (6.67%) 
Eye disorders - Other, blepharitis  1  1/15 (6.67%) 
Flashing lights  1  1/15 (6.67%) 
Gastrointestinal disorders   
Diarrhea  1  11/15 (73.33%) 
Mucositis  1  9/15 (60.00%) 
Nausea  1  9/15 (60.00%) 
Constipation  1  6/15 (40.00%) 
Vomiting  1  6/15 (40.00%) 
Abdominal Pain  1  3/15 (20.00%) 
Dry mouth  1  2/15 (13.33%) 
Gastrointestinal disorders - Other, bloody stools  1  2/15 (13.33%) 
Hemorrhoids  1  2/15 (13.33%) 
Rectal Pain  1  2/15 (13.33%) 
Gastroesophageal reflux disease  1  1/15 (6.67%) 
Gastrointestinal disorders - Other, enlarged tongue  1  1/15 (6.67%) 
Gastrointestinal disorders - Other, stomatitis  1  1/15 (6.67%) 
Gastrointestinal Pain  1  1/15 (6.67%) 
Oral Pain  1  1/15 (6.67%) 
Rectal hemorrhage  1  1/15 (6.67%) 
Toothache  1  1/15 (6.67%) 
General disorders   
Fatigue  1  9/15 (60.00%) 
General disorders and administration site conditions - Other, cold sensitivity  1  4/15 (26.67%) 
Chills  1  2/15 (13.33%) 
Fever  1  2/15 (13.33%) 
Edema limbs  1  1/15 (6.67%) 
infusion related reaction  1  1/15 (6.67%) 
Infections and infestations   
Upper Respiratory Infection  1  2/15 (13.33%) 
Gum infection  1  1/15 (6.67%) 
Infections and infestations - Other, pneumonia  1  1/15 (6.67%) 
Infections and infestations - Other, unknown  1  1/15 (6.67%) 
Joint infection  1  1/15 (6.67%) 
Laryngitis  1  1/15 (6.67%) 
Paronychia  1  1/15 (6.67%) 
Sepsis  1  1/15 (6.67%) 
Sinusitis  1  1/15 (6.67%) 
Skin infection  1  1/15 (6.67%) 
Injury, poisoning and procedural complications   
Burn  1  1/15 (6.67%) 
Fracture  1  1/15 (6.67%) 
Investigations   
White Blood Cell Decreased  1  6/15 (40.00%) 
Neutrophil Count Decreased  1  4/15 (26.67%) 
Platelet Count Decreased  1  4/15 (26.67%) 
Alanine aminotransferase increased  1  3/15 (20.00%) 
Weight loss  1  3/15 (20.00%) 
Aspartate aminotransferase increased  1  2/15 (13.33%) 
Alkaline phosphatase increased  1  1/15 (6.67%) 
Investigations - Other, blood bicarbonate decreased  1  1/15 (6.67%) 
Investigations - Other, blood bicarbonate increased  1  1/15 (6.67%) 
Metabolism and nutrition disorders   
Dehydration  1  6/15 (40.00%) 
Anorexia  1  5/15 (33.33%) 
Hypokalemia  1  5/15 (33.33%) 
Hypomagnesemia  1  4/15 (26.67%) 
Hyperglycemia  1  2/15 (13.33%) 
Hypoalbuminemia  1  1/15 (6.67%) 
Hypoglycemia  1  1/15 (6.67%) 
Hyponatremia  1  1/15 (6.67%) 
Hypophosphatemia  1  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/15 (6.67%) 
Back Pain  1  1/15 (6.67%) 
Generalized muscle weakness  1  1/15 (6.67%) 
Myalgia  1  1/15 (6.67%) 
Pain in Extremity  1  1/15 (6.67%) 
Nervous system disorders   
Peripheral Sensory Neuropathy  1  6/15 (40.00%) 
Dizziness  1  3/15 (20.00%) 
Dysgeusia  1  3/15 (20.00%) 
Dysesthesia  1  2/15 (13.33%) 
Headache  1  2/15 (13.33%) 
Nervous system disorders - Other, speech impairment  1  2/15 (13.33%) 
Memory impairment  1  1/15 (6.67%) 
Psychiatric disorders   
Anxiety  1  3/15 (20.00%) 
Insomnia  1  3/15 (20.00%) 
Depression  1  2/15 (13.33%) 
Renal and urinary disorders   
Bladder spasm  1  1/15 (6.67%) 
Renal and urinary disorders - Other, acute renal insufficiency  1  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/15 (6.67%) 
Cough  1  1/15 (6.67%) 
Epistaxis  1  1/15 (6.67%) 
Hoarseness  1  1/15 (6.67%) 
Sore Throat  1  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Rash  1  13/15 (86.67%) 
Alopecia  1  2/15 (13.33%) 
Nail discoloration  1  2/15 (13.33%) 
Palmar-plantar erythrodysesthesia syndrome  1  1/15 (6.67%) 
Pruritus  1  1/15 (6.67%) 
Skin hyperpigmentation  1  1/15 (6.67%) 
Vascular disorders   
Hypertension  1  2/15 (13.33%) 
Hypotension  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01226719     History of Changes
Other Study ID Numbers: SCRI GI 134
First Submitted: October 15, 2010
First Posted: October 22, 2010
Results First Submitted: February 26, 2015
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015