Neuroendocrine Tumor of Pancreas, Pancreatic Neuroendocrine Tumors
Conditions
Keywords
Lurbinectedin, Neuroendocrine Tumors
Brief summary
* Pancreatic neuroendocrine tumor (pNET) is a rare form of cancer. Treatment options such as hormonal therapy (octreotide) and targeted therapy (everolimus and sunitinib) may be considered for grade 1 or 2 pNETs; however, cytotoxic chemotherapy is essential in cases with grade 3 pNETs or pNECs. * Cisplatin/etoposide remains the treatment of choice for high-grade pNET/pNEC. Other irinotecan-based therapies, such as FOLFIRI (cisplatin/irinotecan), FOLFOX, and temozolomide ± capecitabine, have been employed; however, a standard of care remains to be established.
Detailed description
* Lurbinectedin, a selective inhibitor of oncogenic transcription, recently received accelerated FDA approval for lung cancer (small cell type) after demonstrating efficacy in an open-label, phase II basket study (ORR 35%, mOS 9.3 months, mPFS 3.5 months). * A previous study that involved patients with grade 2 or higher NET/NEC who had undergone treatment with lurbinectedin revealed that the ORR, mOS, and mPFS of the six patients with pNET was 6.5%, 7.4 months, and 1.4 months, respectively.
Interventions
Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.
Sponsors
Seoul National University Bundang Hospital
Samsung Medical Center
Seoul National Hospital
Gangnam Severance Hospital
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Pancreatic neuroendocrine tumor or neuroendocrine carcinoma * Documented failure of prior standard anti-cancer treatment * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³ * Platelet count ≥ 100,000 cells/mm³ * Ability to understand study content, willingness to comply with study procedures, and commitment to complete the study
Exclusion criteria
* Currently receiving treatment for other cancers (except those who completed treatment and have been disease-free for at least 2 years prior to enrollment) * Pregnant or breastfeeding women * Deemed unsuitable for participation by the investigator due to clinical or medical reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall response rate | From date of first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24months | The proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by the investigators according to the Response Evaluation Criteria in Solid Tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | From date of the first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 1\. Disease control is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigators per RECIST v1.1 criteria. |
| Duration of response | From date of first documented response until the date of disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 24 months. | from date of first response to the date of disease progression, relapse, or death |
| Evaluate the safety and tolerability of Lurbinectedin | From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months. | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Progression-free survival | From the date of first infusion until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months. | time from the date of first infusion to disease progression or death from any cause |
| Overall survival | from the date of first infusion until death from any cause or loss to follow-up, whichever occurs first, assessed up to 24 months. | from the date of first infusion to death or loss to follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tissue and blood sampling for discovering biomarkers | Every 6 weeks (two 28-day cycles) until the end of Cycle 6, and then every 9 weeks (three 28-day cycles) until documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months. | Biomarker should be identified by statistical methods for correlation between disease control rates, response duration, progression-free survival, and overall survival. |
Countries
South Korea
Outcome results
None listed