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Colorectal CancerPhase 2PLANETNCT00885885

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

A Phase 2 study testing Panitumumab+FOLFOX-4 and Panitumumab+FOLFIRI in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Panitumumab+FOLFOX-4 and Panitumumab+FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
May 2009to Mar 2015
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Number of liver metastasis ≥ 4.
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  • Size of one liver metastasis > 10 cm in diameter.
  • Liver metastases technically not resectable.
  • At least 1 uni-dimensionally measurable lesion
  • Patients with the following characteristics will be included:
  • 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
  • Recurrence after surgical treatment and/or radiotherapy with no adjuvant systemic treatment.
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

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.

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.

Being tested
Panitumumab+FOLFOX-4, Panitumumab+FOLFIRI
Keywords
Colorectal Cancer, Panitumumab, FOLFOX-4, FOLFIRI
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Panitumumab+FOLFOX-4Drug

    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

  • Panitumumab+FOLFIRIDrug

    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.
Study groups in NCT00885885
Study groupRoleWhat they receive
1ExperimentalPanitumumab+FOLFOX 4
Receives: Drug: Panitumumab+FOLFOX-4
2ExperimentalPanitumumab+FOLFIRI
Receives: Drug: Panitumumab+FOLFIRI

What is being measured

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

  1. Objective response rate

    Measured: 2009-2013

Secondary outcomes (8)

  1. % of patients whose disease becomes resectable

    Measured: 2009-2013

  2. Time to resection

    Measured: 2009-2013

  3. Duration of response

    Measured: 2009-2013

  4. Progression-free survival

    Measured: 2009-2013

  5. Time to treatment failure

    Measured: 2009-2013

  6. Time to disease relapse following surgery.

    Measured: 2009-2013

  7. Adverse Events

    Measured: 2009-2013

  8. Evaluation of molecular predictive markers for response.

    Measured: 2009-2013

Timeline

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

  1. First posted22 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2015
  4. Study completionMar 2015

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00885885
Sponsor's protocol ID
TTD-08-04
Other IDs
EudraCT: 2008-006766-28
Acronym
PLANET
Status last verified
Jul 2017
First submitted
21 Apr 2009
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Benavides M, Diaz-Rubio E, Carrato A, Abad A, Guillen C, Garcia-Alfonso P, Gil S, Cano MT, Safont MJ, Gravalos C, Manzano JL, Sanchez A, Alcaide J, Lopez R, Massuti B, Sastre J, Martinez E, Escudero P, Mendez M, Aranda E. Tumour location and efficacy of first-line EGFR inhibitors in KRAS/RAS wild-type metastatic colorectal cancer: retrospective analyses of two phase II randomised Spanish TTD trials. ESMO Open. 2019 Dec 1;4(6):e000599. doi: 10.1136/esmoopen-2019-000599. eCollection 2019.

    PubMed 31803504

  • Carrato A, Abad A, Massuti B, Gravalos C, Escudero P, Longo-Munoz F, Manzano JL, Gomez A, Safont MJ, Gallego J, Garcia-Paredes B, Pericay C, Duenas R, Rivera F, Losa F, Valladares-Ayerbes M, Gonzalez E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). First-line panitumumab plus FOLFOX4 or FOLFIRI in colorectal cancer with multiple or unresectable liver metastases: A randomised, phase II trial (PLANET-TTD). Eur J Cancer. 2017 Aug;81:191-202. doi: 10.1016/j.ejca.2017.04.024. Epub 2017 Jun 19.

    PubMed 28633089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab+FOLFOX-4 and Panitumumab+FOLFIRI in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 22 inclusion and 21 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 1 Aug 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 Spain. 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 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?

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?

Objective response rate (time frame: 2009-2013). 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 NCT00885885, which also lists 2 linked publications.

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 1 Aug 2017.

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