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Colorectal CancerPhase 2NCT00111761

Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing Irinotecan, Panitumumab and 5-Fluorouracil in people with Colorectal Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Irinotecan, Panitumumab and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
Jul 2002to Oct 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to comprehend and sign an Institutional Review Board (IRB)-approved informed consent form
  • Pathologic diagnosis of colorectal cancer - Metastatic colorectal adenocarcinoma
  • If history of adjuvant chemotherapy for colorectal cancer, must have been free of disease for greater than or equal to 1 year after completion of adjuvant chemotherapy
  • Unidimensionally measurable disease
  • Paraffin-embedded tumor tissue available for immunohistochemistry studies of epidermal growth factor receptor (EGFr) expression (archived tissue is acceptable)
  • Tumor over-expressing EGFr by immunohistochemistry (staining must be the sum of 1+, 2+ and 3+ in greater than or equal to 10% of evaluated tumor cells; staining and evaluation to be conducted at a central laboratory)
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Adequate hematologic, renal, and hepatic function

Who cannot join

  • Female (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last ABX-EGF infusion
  • Female who is breast-feeding or pregnant
  • Any kind of disorder that compromises the ability of the patient to give written informed consent and/or comply with the study procedures
  • History of any chronic 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 compliance or the interpretation of study results
  • Untreated brain metastases
  • Therapy for colorectal cancer other than surgery and 5-FU-based adjuvant therapy
Show all 32Show fewer
  • Prior treatment for metastatic colorectal cancer
  • Prior irinotecan
  • Prior or concurrent radiation therapy for colorectal cancer, including prior adjuvant radiation therapy to the pelvis
  • Known allergy to irinotecan, 5-fluorouracil, or leucovorin
  • Known Gilbert's disease
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Prior EGFr-targeting agents
  • Use of investigational therapy used with adjuvant intent within 30 days before the first ABX-EGF infusion
  • If prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, no treatment or active disease within 5 years
  • Active inflammatory bowel disease or other bowel disease (other than colorectal carcinoma) causing chronic diarrhea (defined as greater than 4 stools per day)
  • Partial or complete bowel obstruction, known chronic malabsorption, total colectomy, or other major abdominal surgery that might result in substantial alteration in transit to absorption of oral medication
  • Ascites or pleural effusion requiring therapeutic paracentesis or thoracentesis; subject with small, stable, asymptomatic pleural effusions or ascites may be enrolled; subject who has been rendered asymptomatic by successful sclerosis of an effusion may be enrolled.
  • Active interstitial pneumonia or interstitial fibrosis
  • Left ventricular ejection fraction (LVEF) less than 45%, as measured by multiple-gated acquisition (MUGA) scan - Myocardial infarction within 1 year before the first ABX-EGF infusion
  • Any of the following within 6 months before the first study drug dose:
  • Unstable angina;
  • Symptomatic congestive heart failure;
  • Serious uncontrolled cardiac arrhythmia;
  • Cerebrovascular accident or transient ischemic attack;
  • Pulmonary embolism;
  • Deep vein thrombosis;
  • Other significant thromboembolic event.
  • Subject known to be human immunodeficiency virus (HIV) positive
  • History of any chronic 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 patient compliance or the interpretation of study results
  • Unwilling or unable to comply with study requirements
  • Known allergy to the ingredients of the study drug or to Staphylococcus protein A

About this study

Official title: A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil in Subjects With Metastatic Colorectal Cancer

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Read the detailed description

Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).

Secondary Objective(s) To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).

To assess the pharmacokinetics (PK) of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen, and the PK of irinotecan (IR) and its active metabolite SN-38 when IR is given in combination with ABX-EGF, leucovorin (LV), and 5-fluorouracil (5-FU) in subjects with metastatic colorectal cancer)

Being tested
Irinotecan, Panitumumab, 5-Fluorouracil, Leucovorin
Keywords
Immunex, Panitumumab, ABX-EGF, Abgenix
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    Part 1: 125 mg/m^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m^2 IV infusion every other week until disease progression or unable to tolerate.

  • PanitumumabBiological

    Also called ABX-EGF

    Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.

  • 5-FluorouracilDrug

    Part 1: IV bolus 500 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m^2 and infusional 2400-3000 mg/m^2 over 46 hours once every other week until disease progression or unable to tolerate.

  • LeucovorinDrug

    Part 1: IV bolus 20 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m^2 every other week until disease progression or unable to tolerate.

Study groups in NCT00111761
Study groupRoleWhat they receive
Part 1: Panitumumab + IFLExperimentalPanitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen)
Receives: Drug: Irinotecan; Biological: Panitumumab; Drug: 5-Fluorouracil; Drug: Leucovorin
Part 2: Panitumumab + FOLFIRIExperimentalPanitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Receives: Drug: Irinotecan; Biological: Panitumumab; Drug: 5-Fluorouracil; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)

    The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

    Measured: Until disease progression (median 47 weeks)

  2. Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)

    The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).

    Measured: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Secondary outcomes (11)

  1. Number of Participants With an Objective Tumor Response (Part 2)

    Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.

    Measured: Until disease progression (median 47 weeks)

  2. Time to Disease Progression (Part 2)

    Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.

    Measured: From enrollment until death or diease progression. Maximum follow-up time was 16 months.

  3. Progression-free Survival Time (Part 2)

    Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.

    Measured: From enrollment until disease progression or death. Maximum follow-up time was 16 months.

  4. Survival Time (Part 2)

    Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.

    Measured: From enrollment until death. Maximum follow-up time was 16 months.

  5. Number of Participants Who Died (Part 2)

    The number of participants in Part 2 who died during the study.

    Measured: From enrollment until last contact. Maximum follow-up was 16 months.

  6. Number of Participants With Objective Tumor Response (Part 1)

    Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.

    Measured: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

  7. Progression-free Survival Time (Part 1)

    Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.

    Measured: From enrollment until disease progression or death. Maximum follow-up time was 25 months.

  8. Time to Disease Progression (Part 1)

    Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.

    Measured: From enrollment until disease progression or death. Maximum follow-up time was 25 months.

  9. Survival Time (Part 1)

    Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.

    Measured: From enrollment until death. Maximum follow-up time was 25 months.

  10. Time to Treatment Failure (Part 1)

    Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.

    Measured: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

  11. Time to Initial Objective Tumor Response (Part 1)

    Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.

    Measured: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2005 (estimated)
  2. Study startJul 2002
  3. Primary completionFeb 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111761
Sponsor's protocol ID
20025409
Status last verified
Nov 2013
First submitted
25 May 2005
Last updated
12 Dec 2013
Data monitoring committee
Yes

Publications

  • Berlin J, Posey J, Tchekmedyian S, Hu E, Chan D, Malik I, Yang L, Amado RG, Hecht JR. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007 Mar;6(6):427-32. doi: 10.3816/CCC.2007.n.011.

    PubMed 17531105

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Panitumumab and 5-Fluorouracil in people with Colorectal Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2) (time frame: Until disease progression (median 47 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.

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