Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases (PLANET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT00885885
First received: April 21, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.


Condition Intervention Phase
Colorectal Cancer
Drug: Panitumumab+FOLFOX-4
Drug: Panitumumab+FOLFIRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Randomized, Multi-Centre Exploratory Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With FOLFOX 4 Chemotherapy or Panitumumab With FOLFIRI Chemotherapy in Subjects With Wild- Type KRAS Colorectal Cancer and Liver-only Metastases.

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % of patients whose disease becomes resectable [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Time to resection [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Time to disease relapse following surgery. [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 2009-2013 ] [ Designated as safety issue: Yes ]
  • Evaluation of molecular predictive markers for response. [ Time Frame: 2009-2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Panitumumab+FOLFOX 4
Drug: Panitumumab+FOLFOX-4

Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.

A cycle of panitumumab is defined as 14 days.

FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle:

  • Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle
  • Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2
  • A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2
  • 5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2
Experimental: 2
Panitumumab+FOLFIRI
Drug: Panitumumab+FOLFIRI

Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.

A cycle of panitumumab is defined as 14 days.

FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle:

  • Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle
  • Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing
  • A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1
  • 5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman > 18 years < 75 of age
  • Competent to comprehend, sign, and date an IEC-approved informed consent form
  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Wild Type KRAS status
  • Metastatic colorectal carcinoma exclusively affecting only the liver, compliant with one of the following criteria

    1. Number of liver metastasis ≥ 4.
    2. Size of one liver metastasis > 10 cm in diameter.
    3. Liver metastases technically not resectable.
  • At least 1 uni-dimensionally measurable lesion
  • Patients with the following characteristics will be included:

    1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval > than 6 months after its completion; or after oxaliplatin containing adjuvant treatment with a disease-free interval > than 12 months
    2. Recurrence after surgical treatment and/or radiotherapy with no adjuvant systemic treatment.
    3. De novo diagnosis of the disease.
  • Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior chemotherapy.
  • Prior radiotherapy is acceptable.
  • Patients deemed to have no major contra-indication to liver surgery from a general health perspective.
  • Karnofsky performance status ≥ 70%
  • Adequate bone marrow function: neutrophils ≥ 1.5 x109/ L; platelets ≥ 100 x109/ L;hemoglobin ≥ 9g/ dL
  • Hepatic and metabolic function as follows:

Total bilirubin count ≤ 1.5 x ULN and not increasing more than 25% within the last 4 weeks; ALAT and ASAT < 5 x ULN;

  • Renal function, calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
  • Magnesium > LLN

Exclusion Criteria:

  • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib).Subjects who have experienced an infusion reaction to their first dose of anti-EGFR therapy (cetuximab) may participate in this clinical trial.
  • Surgery (not including diagnostic biopsy) and/or radiotherapy in the 4 weeks prior to inclusion in the study.
  • Metastasis on any site other than the liver, including extrahepatic lymph nodes.
  • Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive carcinoma of the skin.
  • Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
  • Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
  • Treatment for systemic infection within 14 days before initiating study treatment
  • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day)
  • History of Gilbert's syndrome or dihydropyrimidine deficiency
  • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • subject allergic to the ingredients of the study medication or to Staphylococcus protein A
  • Any co-morbid disease that would increase risk of toxicity
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
  • Any investigational agent within 30 days before enrolment
  • Must not have had a major surgical procedure within 28 days of randomization
  • Subject who is pregnant or breast feeding
  • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (eg diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men
  • Subject unwilling or unable to comply with study requirements
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885885

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Amgen
Investigators
Study Chair: Albert Abad, MD, phD ICO-H. Germans Trial i Pujol. Badalona. Spain
Study Chair: Alfredo Carrato, MD, phD Hospial Ramón y Cajal. Madrid. Spain
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT00885885     History of Changes
Other Study ID Numbers: TTD-08-04, EudraCT: 2008-006766-28
Study First Received: April 21, 2009
Last Updated: March 26, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
Colorectal Cancer
Panitumumab
FOLFOX-4
FOLFIRI

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014