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Gastro-entero-pancreatic Neuroendocrine TumorsPhase 2Lu-Ca-SNCT02736448

177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors

A Phase 2 study testing Capecitabine, Lu-PRRT and SS-LAR in people with Gastro-entero-pancreatic Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and will be randomly assigned to 2 different… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Capecitabine, Lu-PRRT and SS-LAR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteItaly
Study dates
May 2016to 30 Apr 2023
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologic diagnosis of gastro-entero-pancreatic neuroendocrine tumor, well differentiated G1 - G2 (ki67≤20%) and G3 (ki67≤50%)
  • Male or Female, aged >18 years
  • Measurable disease according to RECIST 1.1 criteria
  • Patients with documented disease will be admitted to therapeutic phase only if the diagnostic receptor imaging, OctreoScan, with a significant uptake in the tumor (grade 2 or 3, according to Rotterdam scale) and/or PET/CT 68Gallium (68Ga)-peptide images with a tumor uptake at least equal to liver background
  • Patients with documented disease will be admitted to therapeutic phase only if the 18FDG PET/CT is positive with a standardized uptake value (SUV) > 2.5 at least in one documented lesion.
  • Non operable advanced disease
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  • Documented progression after standard therapy such as long acting octreotide or lanreotide (SS-LAR), Everolimus in P-NETs or platinum based therapy in G3 patients.
  • Patients have to finish prior standard chemotherapy or therapeutical radiotherapy (less then 25% body surface) at least 6 weeks
  • Life expectancy greater than 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate haematological, liver and renal function: haemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin ≤ 2.5 X upper normal limit (UNL) , Alanine transaminase (ALT) <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL.
  • Concomitant SS-sub-cutaneous assumption is allowed in case of carcinoid syndrome
  • If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) (See Appendix H) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months.
  • Participant is willing and able to give informed consent for participation in the study.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.

Who cannot join

  • Ki 67 index > 50%
  • FDG PET negative
  • Patients treated with chemotherapy and therapeutic radiotherapy within 6 weeks
  • More then 25% body surface radiotherapy
  • Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 23 Gy and 1,2 Gy for the bone marrow or as surrogate of dosimetry, a Total Cumulative Activity (TCA) of >250 millicurie (mCi) of 90Y dotatoc or >800 (mCi) of 177Lutethium (177Lu) dotatate
  • All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
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  • Life expectancy minor than 6 months.
  • ECOG performance status >2
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Known hypersensitivity to Octreotide and/or Lanreotide, and/or somatostatin correlate peptides
  • Known hypersensitivity to capecitabine or to any of its components
  • Known hypersensitivity to 5 - fluorouracil.
  • Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Irst Irccs

    Meldola, FC, 47014

Other trials in Italy

About this study

Official title: 177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors: a Randomized Phase II Study.

This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and will be randomly assigned to 2 different arms:

  • Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR
  • Arm Lu-PRRT: Lu-PRRT (at 3.7 gigabecquerel (Gbq) per cycle x 7 cycles) followed by SS-LAR.
Read the detailed description

This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), SSR positive and 18-fluorodeoxyglucose (FDG) positive will be enrolled in the study and will be randomly assigned to 2 different arms:

  • Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR
  • Arm Lu-PRRT: Lu-PRRT (at 3.7Gbq per cycle x 7 cycles) followed by SS-LAR. The primary objective is to evaluate the progression free survival (PFS) in the two arms.

The secondary objectives are: i) the efficacy (disease control rate, DCR), ii) acute and late toxicity, and iii) overall survival (OS).

The investigators plan to enroll 176 patients during a period of 36 months and a period of 36 months of follow up

Being tested
Capecitabine, Lu-PRRT, SS-LAR
Keywords
GEP-NET tumors, Lu-PRRT, 177Lutethium - Peptide Receptor Radionuclide Therapy, gastro-entero-pancreatic neuroendocrine tumors, 18-FDG Positron Emission Tomography (PET) positive, low dose of capecitabine

What participants receive

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

  • CapecitabineDrug

    oral low dose of capecitabine

  • Lu-PRRTDrug

    Lu-PRRT (at 3.7Gbq per cycle x 7 cycles)

  • SS-LARDrug

    long acting octreotide or lanreotide

Study groups in NCT02736448
Study groupRoleWhat they receive
Arm Lu-PRRT-CapExperimentalArm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR)
Receives: Drug: Capecitabine; Drug: Lu-PRRT; Drug: SS-LAR
Arm Lu-PRRTExperimentalArm Lu-PRRT: Lu-PRRT (at 3.7Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR)
Receives: Drug: Lu-PRRT; Drug: SS-LAR

What is being measured

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

  1. Progression free survival

    Progression free survival is defined as the time from the randomization date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

    Measured: up to 72 months

Secondary outcomes (2)

  1. Disease control rate

    DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: up to 72 months

  2. Acute and late toxicity

    The acute toxicity is the toxicity that occurred within 30 days from the last treatment administration. The late toxicity is the toxicity that occurred over 30 days from the last treatment administration. NCI-CTCAE v. 4.03 will be applied and a profile of adverse events related to the study drug will be described.

    Measured: up to 72 months

Timeline

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

  1. First posted13 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2019
  4. Study completion30 Apr 2023

Why it stopped: Following the publication in the Official Journal of the reclassification of the drug LUTATHERA in band H, it was decided to close the enrolment early on 30/Aug/19.

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736448
Sponsor's protocol ID
IRST100.17
Other IDs
2014-003067-38, 2014
Acronym
Lu-Ca-S
Status last verified
Jan 2025
First submitted
7 Apr 2016
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Lu-PRRT and SS-LAR in people with Gastro-entero-pancreatic Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS 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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Jan 2025. 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 was stopped early (reason given: Following the publication in the Official Journal of the reclassification of the drug LUTATHERA in band H, it was decided to close the enrolment early on 30/Aug/19.). Results are not available in the source record.

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?

Progression free survival (time frame: up to 72 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 NCT02736448.

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 13 Jan 2025.

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