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Colorectal CancerPhase 1/2PIENCT01139138

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

A Phase 1/2 study testing Panitumumab, Irinotecan and Everolimus in people with Colorectal Cancer and Colorectal Carcinoma, run by The Queen Elizabeth Hospital at 1 site in Australia.

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

This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Panitumumab, Irinotecan and Everolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteAustralia
Study dates
Jun 2010to Jun 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Age > 18 years
  • Histological diagnosis of colorectal cancer that is KRAS wild type
  • Metastatic disease not amenable to resection
  • Measurable disease as assessed by CT scan using RECIST criteria
  • Received and failed fluoropyrimidine therapy
  • Radiographically documented disease progression per RECIST criteria
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  • For phase 1b group only, ECOG PS 0-1
  • For phase 2 group only, ECOG PS 0-2
  • Adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 109/l; neutrophils > 1.5 X 109/l within 7 days of enrolment
  • Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault) within 7 days of enrolment
  • Adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range and ALT or AST<2.5xULN (<5xULN if liver metastases present) within 7 days of enrolment
  • Magnesium ≥ lower limit of normal within 7 days of enrolment.
  • Fasting serum cholesterol ≤ 7.75mmol/L AND fasting triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Life expectancy of at least 12 weeks
  • Negative pregnancy test ≤ 72 hours before commencing study treatment (women of childbearing potential only).
  • Written informed consent including consent for biomarker studies

Who cannot join

  • Presence of KRAS mutation in tumour sample
  • For Phase 1b group only, patients with prior pelvic radiotherapy.
  • Systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment
  • Radiotherapy within 14 days of commencing study treatment.
  • Unresolved toxicities from prior systemic therapy or radiotherapy
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol
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  • Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
  • Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
  • Prior therapy with irinotecan
  • CYP3A4 enzyme inducing anti-convulsant medication ≤ 14 days prior to study treatment.
  • Ketoconazole ≤ 7 days before study treatment.
  • Uncontrolled diabetes mellitus defined by fasting glucose >1.5 x ULN.
  • Known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
  • Patients with known interstitial lung disease or severely impaired lung function
  • Patients with active bleeding diatheses.
  • Any uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
  • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
  • Chronic treatment with immunosuppressives
  • Patients with a known history of HIV seropositivity
  • Patients who have any severe and/or uncontrolled medical conditions or infections
  • Untreated or symptomatic CNS metastases
  • Patients who have a history of another primary malignant disease
  • Pregnancy or lactation.
  • Women and partners of women of childbearing potential who are not using effective contraception.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

Other trials in Australia

About this study

Official title: A Phase IB/II Study of Second Line Therapy With Panitumumab, Irinotecan and Everolimus (PIE) in Metastatic Colorectal Cancer With KRAS WT

This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer

Read the detailed description

This is an open label uncontrolled phase IB/II study to determine the maximum tolerated dose (MTD) and assess the efficacy of everolimus, irinotecan and panitumumab when given in combination for patients with metastatic colorectal cancer and KRAS wild-type (WT). Patients with metastatic colorectal cancer (mCRC) that have failed fluorouracil based first line therapy will be included. It is anticipated that approximately 50 patients will be enrolled over a period of 24 months

Being tested
Panitumumab, Irinotecan, Everolimus
Keywords
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • PanitumumabDrug

    Also called Vectibix

    Panitumumab 6mg/kg IV every 14 days

  • IrinotecanDrug

    Irinotecan 200mg/m2 IV every 14 days

  • EverolimusDrug

    Also called RAD001

    Everolimus daily po (dosage varies with cohort)

Study groups in NCT01139138
Study groupRoleWhat they receive
Panitumumab + Irinotecan + EverolimusExperimentalNot described
Receives: Drug: Panitumumab; Drug: Irinotecan; Drug: Everolimus

What is being measured

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

  1. Dose limiting toxicities

    To determine the maximum tolerated dose (MTD)of everolimus, irinotecan and panitumumab when given in combination for patients with Kras WT mCRC

    Measured: at end of cycle 2 (each cycle is 14 days)

Secondary outcomes (4)

  1. Safety & toxicity

    Safety and toxicity assessed weekly during the phase Ib component (as per NCI CTCAE version 3.0) and fortnightly during the phase II component

    Measured: Approximately 24 weeks

  2. Response rate

    Objective tumour response as per RECIST criteria V1.0

    Measured: Assessed every 6 weeks until disease progression

  3. Progression free survival

    Measured: Until disease progression, occurrence of new disease or death

  4. Overall Survival

    Measured: Assessed 3 monthly until death

Timeline

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

  1. First posted8 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2015
  4. Study completionJun 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01139138
Sponsor's protocol ID
AU-2009-0003/CRAD001CAU06T
Acronym
PIE
Status last verified
Nov 2017
First submitted
28 May 2010
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Panitumumab, Irinotecan and Everolimus in people with Colorectal Cancer and Colorectal Carcinoma, run by The Queen Elizabeth Hospital at 1 site in Australia.

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 16 inclusion and 24 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose limiting toxicities (time frame: at end of cycle 2 (each cycle is 14 days)). 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 NCT01139138.

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 6 Nov 2017.

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