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Cancer Vaccine

Fulvestrant + Lu-DOTATATE for Pancreatic Neuroendocrine Tumors

Phase 1

Waitlist Available

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients should not have received prior systemic therapy with peptide receptor radionuclide therapy and/or Fulvestrant

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

Must not have

Patients with known untreated brain metastases

Clinical or laboratory signs of imminent organ failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of using Fulvestrant in combination with 177Lu-DOTATATE for treating advanced pancreatic neuroendocrine tumors.

Who is the study for?

This trial is for adults with advanced pancreatic neuroendocrine tumors (pNETs) who have progressed after standard therapy. Participants must be able to perform daily activities with minimal assistance and have acceptable blood test results.

What is being tested?

The study tests the safety and initial effectiveness of combining Fulvestrant, a hormone therapy, with Lu-DOTATATE, a radioactive drug targeting tumor cells in patients with pNETs. It's an early-stage trial where everyone gets both treatments.

What are the potential side effects?

Possible side effects include nausea, vomiting, fatigue, low blood counts that can increase infection risk or cause bleeding problems, liver toxicity, kidney damage from radiation exposure and hormonal changes due to Fulvestrant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had treatments with peptide receptor radionuclide therapy or Fulvestrant.

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My cancer cannot be removed by surgery and may have spread.

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My tumor has somatostatin receptors.

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My cancer has worsened after treatment.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My organs and bone marrow are working well.

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I am HIV positive, on treatment, and my viral load is undetectable.

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My chronic hepatitis B virus infection is under control with an undetectable viral load.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

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I do not have any other active cancers or blood conditions.

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My pancreatic tumor is a slow-growing type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that have not been treated.

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My organs are at risk of failing soon.

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I have another active cancer besides non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Safety

Secondary study objectives

Overall Survival

Progression Free Survival

Other study objectives

To examine tumor expression in tumor samples.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Safety-Run InExperimental Treatment2 Interventions

Safety and tolerability data of the combination treatment from the first 6 patients who complete at least 28 days of safety follow-up after the first dose of combination treatment. If no significant safety issues are identified the study will proceed to Arm 2 (dose expansion).

Group II: Dose-ExpansionExperimental Treatment2 Interventions

Stage 2 will enroll an additional 13 patients for dose expansion. Fulvestrant and 177Lu-DOTATATE will be given at doses 500 mg IM and 7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

177Lu-DOTATATE

2010

Completed Phase 2

~150

Fulvestrant

2011

Completed Phase 3

~4030