Health TrialsbyHealthPanel

Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

ConditionMetastatic Pancreatic Neuroendocrine Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index of <20%.

Patients must have locally advanced disease that is ineligible for curative-intent resection, or metastatic disease.

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 for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.

Patients must also have tumors expressing somatostatin receptor, defined as radiotracer avid lesions as assessed by a previous DOTATATE PET scan.

Disqualifiers

Patients who are unable to provide or understand written informed consent and comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.

Patients who are receiving any other investigational agents.

Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.

Pregnant or breastfeeding.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Fulvestrant

    Drug

    Safety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.

  • 177Lu-DOTATATE

    Drug

    Safety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Safety-Run InExperimental treatment 2 interventions
Group B: Dose-ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The rates of tumor response categories (CR, PR, SD, PD, Not Evaluated, Too Early) will be summarized and compared to historical control of response to PRRT treatment.

Time frame
Through study completion, an average of 2 years
2

Safety

Safety will be measured by the incidence of adverse events and serious adverse events.

Time frame
8 months for duration of the treatment (until the post-treatment safety follow-up visit)

Secondary outcomes

1

Progression Free Survival

Time from registration to either disease progression or death.

Time frame
Through study completion, an average of 2 years
2

Progression Free Survival

Time from registration to either disease progression or death after 12 months

Time frame
12 months
3

Overall Survival

Time from registration to death.

Time frame
Through study completion, an average of 2 years
4

Overall Survival

Time from registration to death after 12 months.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
Apply now