Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas

NCT04122911 | Completed Phase 2

• 1 other identifier: TENEC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuroendocrine Carcinomas

Keywords

Temozolomide; second-line chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Overall response rate (ORR)

  6 months

Secondary Outcomes (9)

• Second Line Progression Free Survival (PFS)

  12 months

• Overall survival (OS)

  12 months

• Clinical Benefit Rate (CBR)

  12 month

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

  1 month

• Safety and tolerability - Incidence of abnormal laboratory test results

  1 month

Study Arms (1)

Temozolomide

EXPERIMENTAL

Temozolomide 75mg/m2 metronomic schedule: one week on/one week off in a cycle of 28 days

Drug: Temozolomide

Interventions

Temozolomide DRUG

pharmacological

Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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
• 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).

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Tumori di Napoli - Fondazione G. Pascale

Napoli, Campania, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 38615472 DERIVED

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 10, 2019
• Study Start: January 29, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 16, 2019
• Last Updated: October 26, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)