Neuroendocrine TumorsPhase 2NCT01237457
177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
A Phase 2 study testing 177Lu-DOTATATE in people with Neuroendocrine Tumors, run by Ebrahim S Delpassand at 1 site in United States.
Trial summary
This is a phase II treatment protocol evaluating 177Lu-DOTATATE therapy for somatostatin receptor-expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin, and endocrine (examples: pheochromocytoma, medullary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTATATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2010to 25 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)
- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.
- Life Expectancy greater than 12 weeks.
- Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.
- Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
- Total Bilirubin ≤ 3X UNL.
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- Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.
- All patients must have a Karnofsky performance status of at least 60%
- Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis
Who cannot join
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.
- Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
- Uncontrolled congestive heart failure.
- Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
- Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study
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- Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.
- In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up.
- Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- Prior radiation therapy to more than 25% of the bone marrow.
- Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
About this study
This is a phase II treatment protocol evaluating 177Lu-DOTATATE therapy for somatostatin receptor-expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin, and endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non-radioiodine avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small cell lung, Carcinoid, and pancreatic islet cell malignancies).
- Conditions
- Neuroendocrine Tumors
- Being tested
- 177Lu-DOTATATE
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTATATEDrug
Patients will receive 200mCi dose of 177Lu Dotatate
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients with somatostatin receptor-expressing neuroendocrine neoplasms will receive up to 200 mCi of 177Lu-DOTATATE every 6-11 weeks, preferably 6-9 weeks to a cumulative dose of 800 mCi. Receives: Drug: 177Lu-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
Overall response will be determined by Progression Free Survival (PFS). PFS will be calculated as a function of time from start of therapy to time of overall disease progression. Patients will be censored at the date of last contact
Measured: one year after completion of last treatment cycle
Secondary outcomes (1)
Dose limiting toxicity
Patients will be monitored for dose toxicity according to NCI guidelines
Measured: one year after completion of the fourth cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study start27 Oct 2010
- Primary completion17 Nov 2016
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebrahim S Delpassand
- Sponsor type
- University, hospital or other
- Collaborators
- Excel Diagnostics and Nuclear Oncology Center
- Responsible party
- Sponsor-investigator, Ebrahim S Delpassand, Excel Diagnostics and Nuclear Oncology Center
- Investigators
- Ebrahim S Delpassand, M.D, Principal investigator, Excel Diagnostics and Nuclear Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237457
- Sponsor's protocol ID
- 78,256
- Status last verified
- Mar 2023
- First submitted
- 8 Nov 2010
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT01237457
- Acronym / sponsor ID
- 78,256
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ebrahim S DelpassandUniversity, hospital or other
- Collaborators
- Excel Diagnostics and Nuclear Oncology Center
- Study start
- 27 Oct 2010 (actual)
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II treatment protocol evaluating 177Lu-DOTATATE therapy for somatostatin receptor-expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin, and endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non-radioiodine avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small cell lung, Carcinoid, and pancreatic islet cell malignancies).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: 177Lu-DOTATATEPatients with somatostatin receptor-expressing neuroendocrine neoplasms will receive up to 200 mCi of 177Lu-DOTATATE every 6-11 weeks, preferably 6-9 weeks to a cumulative dose of 800 mCi. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)
- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.
- Life Expectancy greater than 12 weeks.
- Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.
- Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
Key exclusion criteria (11 listed)
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.
- Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
- Uncontrolled congestive heart failure.
- Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-DOTATATEPatients will receive 200mCi dose of 177Lu Dotatate | Drug | Treatment |
Primary outcome
Progression Free survival
Time frame: one year after completion of last treatment cycle
Overall response will be determined by Progression Free Survival (PFS). PFS will be calculated as a function of time from start of therapy to time of overall disease progression. Patients will be censored at the date of last contact
1 secondary outcome
Dose limiting toxicity
Time frame: one year after completion of the fourth cycle of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebrahim S Delpassand, M.D principal investigator
Excel Diagnostics and Nuclear Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 177Lu-DOTATATE in people with Neuroendocrine Tumors, run by Ebrahim S Delpassand at 1 site in United States.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 20 Mar 2023. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: one year after completion of last treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2023.