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

Study Purpose

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.

Recuitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histopathologic diagnosis of gastro-entero-pancreatic neuroendocrine tumor, well differentiated G1
  • - G2 (ki67≤20%) and G3 (ki67≤50%) 2.
Male or Female, aged >18 years 3. Measurable disease according to RECIST 1.1 criteria 4. 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 5. 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. 6. Non operable advanced disease 7. 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. 8. Patients have to finish prior standard chemotherapy or therapeutical radiotherapy (less then 25% body surface) at least 6 weeks 9. Life expectancy greater than 6 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 11. 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. 12. Concomitant SS-sub-cutaneous assumption is allowed in case of carcinoid syndrome 13. 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. 14. Participant is willing and able to give informed consent for participation in the study. 15. 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.

Exclusion Criteria:

1. Ki 67 index > 50% 2. FDG PET negative 3. Patients treated with chemotherapy and therapeutic radiotherapy within 6 weeks 4. More then 25% body surface radiotherapy 5. 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 6. 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) 7. Life expectancy minor than 6 months. 8. ECOG performance status >2 9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 10. 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. 11. History of allergic reactions attributed to compounds of similar chemical or biologic composition 12. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 13. Known hypersensitivity to Octreotide and/or Lanreotide, and/or somatostatin correlate peptides 14. Known hypersensitivity to capecitabine or to any of its components 15. Known hypersensitivity to 5
  • - fluorouracil.
16. 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 Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02736448

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Gastro-entero-pancreatic Neuroendocrine Tumors
Additional Details

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

Contact a Trial Team

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International Sites

Irst Irccs, Meldola, FC, Italy

Status

Recruiting

Address

Irst Irccs

Meldola, FC, 47014

Site Contact

Giovanni Paganelli, MD

giovanni.paganelli@irst.emr.it

+390543739100

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