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Neuroendocrine CarcinomasPhase 2TENECNCT04122911

Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas

A Phase 2 study testing Temozolomide in people with Neuroendocrine Carcinomas, run by National Cancer Institute, Naples at 1 site in Italy.

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

To assess the efficacy and safety of Temozolomide for second-line treatment of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinomas
What is being tested?
Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteItaly
Study dates
29 Jan 2017to 16 Dec 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.
  • Patients ≥18 years of age.
  • Histologically confirmed Metastatic Neuroendocrine Carcinoma (Ki67>20% Ki67 must be quantified in percentage) with documented progression of disease per investigator assessment following or during first-line platinum-based treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
  • At least 28 days since prior radiation therapy or surgery and recovery from treatment.
  • Patients must have measurable disease which must be evaluable per RECIST v1.1.
  • Estimated life expectancy of ≥12 weeks.

Who cannot join

  • - Patients < 18 years of age
  • Diagnosis of well differentiated G1/G2 NEN
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
  • Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
  • Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
  • Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
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  • Patients with meningeal carcinomatosis
  • Patients with organ allografts requiring immunosuppression
  • Patients with known positive HIV status
  • Patients with a hypersensitivity to Temozolomide or Dacarbazine
  • Any laboratory values at baseline as follows:
  • Hematology:
  • Absolute Neutrophil Count (ANC) <1.5x109/L or 1500/mm3
  • Platelet count <100x109/L
  • Hemoglobin <8 g/dL (Note: hemoglobin levels may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors).
  • Coagulation:
  • International Normalized Ratio (INR) >1.5 except for patients on stable anticoagulant therapy
  • Activated Partial Thromboplastin Time (aPTT) ≥1.5 times upper limit of normal (ULN) or greater than the lower limit of the therapeutic range Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1, Cycle 1.
  • Serum chemistry:
  • Total bilirubin >1.5 times ULN
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >2 times ULN (>5 times ULN for patients with known liver involvement)
  • Alkaline Phosphatase (ALP) >2 times ULN (>5 times ULN for patients with known liver involvement and >7 times ULN for patients with known bone involvement).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Tumori di Napoli - Fondazione G. Pascale

    Naples, Campania, 80131

Other trials in Italy

About this study

Official title: A Phase II Single Arm Trial Evaluating the Efficacy and Safety of Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas Progressing After First-Line Platinum- Based Therapy

To assess the efficacy and safety of Temozolomide for second-line treatment of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy.

Being tested
Temozolomide
Keywords
Temozolomide, second-line chemotherapy
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

Study groups in NCT04122911
Study groupRoleWhat they receive
TemozolomideExperimentalTemozolomide 75mg/m2 metronomic schedule: one week on/one week off in a cycle of 28 days
Receives: Drug: Temozolomide

What is being measured

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

  1. Overall response rate (ORR)

    Overall response rate (ORR)

    Measured: 6 months

Secondary outcomes (9)

  1. Second Line Progression Free Survival (PFS)

    Second Line Progression Free Survival (PFS)

    Measured: 12 months

  2. Overall survival (OS)

    Overall survival (OS)

    Measured: 12 months

  3. Clinical Benefit Rate (CBR)

    Clinical benefit rate (CBR) was defined as the proportion of patients with a complete or partial response or with stable disease (Complete Response + Partial Response + Stable Disease [CR+PR+SD]) at Week 24.

    Measured: 12 month

  4. Safety and tolerability - Incidence of treatment-related adverse events (AE).

    The NCI-CTCAE version 4.0 will be used to evaluate the clinical safety of the treatment in this study. Intensity of all adverse events (AEs) will be graded according to the NCI-CTCAE v 4.0 on a five-point scale (Grade 1 to 5). AEs not listed on the NCI-CTCAE should be graded according below. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life threatening/disabling; Grade 5: Death.

    Measured: 1 month

  5. Safety and tolerability - Incidence of abnormal laboratory test results

    The following assessments will be conducted in order to monitor patient safety:

    1. Hematology tests as per institutional standards.
    2. Biochemistry tests as per institutional standards.
    3. Coagulation tests as per institutional standards.
    4. Pregnancy test for women of child-bearing potential.

    Measured: 1 month

  6. Safety and tolerability - Incidence of abnormal vital signs

    • Blood pressure (mm/Hg)
    • Temperature (°C)

    Measured: 1 month

  7. Safety and tolerability - Incidence of abnormal ECG readings

    This examination is essential to highlight the presence of:

    • arrhythmias,
    • discontinuous heart rhythm changes,
    • ischemia, i.e. reduced blood supply to the heart,
    • presence of ailments such as heartbeat, chest pain, loss of consciousness or dizziness.

    Measured: 1 month

  8. Quality of Life (QoL) - QoL will be assessed using the European Organization for Research and Trial in Cancer QOL core (EORTC QLQ-C30) questionnaire (version 3) [Quality of life questionnaire - QLQ]

    The EORTC QLQ-C30 is a questionaire of 30-item and it incorporates 9 multi-item scales:5 functional scales (Physical,Role,Cognitive,Emotional and Social Functioning);3 symptom scales (Fatigue,Pain and Nausea/Vomiting) and a Global Health Status/QoL scale.6 single item scales are also included (Dyspnoea,Insomnia,Appetite Loss,Constipation,Diarrhoea and Financial Difficulties).Version 3.0 has 4-point scales for the first 5 items comprising the Physical Functioning scale.These are coded with the same response categories as items 6 to 28,namely "1 Not at all" (minimum value),"2 A little","3 Quite a bit" and "4 Very much" (maximum value).The last 2 question foresee a 7-point response scale:minimum value is "1 Very poor",maximum value is "7 Excellent".

    Measured: 1 month

  9. Quality of Life (QoL) - QoL will be assessed using disease specific modules for Neuroendocrine Tumors (NET), the EORTC QLQ GINET21 (EORTC QLQ Gastrointestinal Neuroendocrine Tumors 21).

    The QLQ-GINET21 contains 21 items:4 single-item assessments relating to muscle and/or bone pain (MBP),body image (BI),information (INF) and sexual functioning (SX),together with 17 items organised into 5 proposed scales:endocrine symptoms (ED 3 items),GI symptoms (GI 5 items),treatment-related symptoms (TR 3 items),social functioning (SF) of the new module (SF21, 3 items) and disease-related worries (DRW 3 items).The response format of the questionnaire is a 4-point Likert scale:"1 Not at all" (minimum value),"2 A little","3 Quite a bit" and "4 Very much" (maximum value).

    Measured: 1 month

Timeline

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

  1. First posted10 Oct 2019
  2. Study start29 Jan 2017
  3. Primary completion30 Dec 2017
  4. Study completion16 Dec 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122911
Sponsor's protocol ID
TENEC
Acronym
TENEC
Status last verified
Sep 2020
First submitted
4 Sep 2019
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • von Arx C, Della Vittoria Scarpati G, Cannella L, Clemente O, Marretta AL, Bracigliano A, Picozzi F, Iervolino D, Granata V, Modica R, Bianco A, Mocerino C, Di Mauro A, Pizzolorusso A, Di Sarno A, Ottaiano A, Tafuto S; ENETs Center of Excellence in Naples, Italy and with the endorsement of the Italian Association for Neuroendocrine Tumor IT.A.NET. A new schedule of one week on/one week off temozolomide as second-line treatment of advanced neuroendocrine carcinomas (TENEC-TRIAL): a multicenter, open-label, single-arm, phase II trial. ESMO Open. 2024 May;9(5):103003. doi: 10.1016/j.esmoop.2024.103003. Epub 2024 Apr 13.

    PubMed 38615472

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide in people with Neuroendocrine Carcinomas, run by National Cancer Institute, Naples at 1 site in Italy.

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 7 inclusion and 22 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 26 Oct 2020. 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 Italy. 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?

Overall response rate (ORR) (time frame: 6 months). 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 NCT04122911, 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 26 Oct 2020.

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