Carcinoid SyndromePhase 2NCT01172717
Study of Panitumumab in the Treatment of Carcinoid Syndrome
A Phase 2 study testing Panitumumab in people with Carcinoid Syndrome, run by Boston Medical Center at 2 sites in United States.
Trial summary
The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who fail or do not adequately respond to octreotide or other supportive therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome
- What is being tested?
- Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jul 2013
- 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
- Histologically or cytologically confirmed diagnosis of metastatic carcinoid tumor and carcinoid syndrome
- Measurable disease as defined by RECIST criteria or evaluable disease
- Measurable disease is the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions are lesions that can be accurately measured in at least one dimension with longest diameter greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan.
- Evaluable disease is disease that cannot be measured directly by the size of the tumor but can be evaluated by a validated biomarker assay including 24 hr urine 5-hydroxyindoleacetic acid, serum serotonin, and/or serum chromogranin A.
- All sites of disease must be evaluated less than or equal to 28 days prior to enrollment.
- All subjects must be 18 years of age or older.
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- ECOG performance status of 0 to 2.
- Subjects may have had past or may be receiving current treatment with octreotide.
- Adequate laboratory parameters with all tests to be performed within 72 hours prior to the first dose.
- Absolute neutrophil count greater than or equal to 1.5 x 109/L
- Hemoglobin greater than or equal to 9.0 g/dL
- Platelet count greater than or equal to 100 x 109/L
- Serum creatinine less than 1.5 mg/dL
- Aspartate aminotransferase (AST) less than or equal to 3 times the upper limit of normal, unless with radiographic evidence of liver metastases. If with liver metastases, AST less than 5 times the upper limit of normal.
- Alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal, unless with radiographic evidence of liver metastases. If with liver metastases, AST less than 5 times the upper limit of normal.
- Total Bilirubin less than or equal to 1.5 times the upper limit of normal.
- Magnesium level greater than lower limit of normal
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Woman and men should use adequate birth control for at least 6 months after the last administration of panitumumab.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
Who cannot join
- Evidence of localized carcinoid tumor amenable to surgical resection or chemoembolization.
- People who are asymptomatic from their carcinoid tumors.
- Past treatment with EGFR inhibitors including cetuximab and panitumumab.
- History of active malignancies requiring treatment in the past 5 years with the exception of resected basal cell carcinoma of the skin.
- History of interstitial pneumonitis or pulmonary fibrosis.
- History of cardiac arrhythmia or Q-T prolongation on electrocardiogram.
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- Women who are pregnant or breast feeding.
- Known infection with human immunodeficiency virus (HIV).
- Treatment with chemotherapy, biologics, immunotherapy, vaccines or cytokine therapy within 4 weeks prior to study entry. The use of octreotide is not exclusionary.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of enrollment.
- A negative octreotide scan does not exclude study enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Lahey Clinic
Burlington, Massachusetts, 01805
About this study
Official title: Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome
The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who fail or do not adequately respond to octreotide or other supportive therapies.
- Conditions
- Carcinoid Syndrome
- Being tested
- Panitumumab
- Keywords
- Carcinoid, Carcinoid syndrome
- Medical subject headings
- Serotonin Syndrome, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix, ABX-EGF
Panitumumab will be given by intravenous infusion at a dose of 9 mg/kg on day 1 of study and then every 3 weeks until progression of disease
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab | Experimental | Single arm study Receives: Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measures
Measured: Every 4 cycles
Tumor Marker Evaluations
Measured: Every 2 cycles
Secondary outcomes (1)
Quality of LIfe
Measured: Day 1 each cycle and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Study never began
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Kevan Hartshorn, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172717
- Sponsor's protocol ID
- H-31701
- Status last verified
- Jul 2013
- First submitted
- 28 Jul 2010
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome
- ClinicalTrials.gov ID
- NCT01172717
- Acronym / sponsor ID
- H-31701
- Conditions
- Carcinoid Syndrome
- Keywords
- Carcinoid, Carcinoid syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never began
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jul 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.
The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who fail or do not adequately respond to octreotide or other supportive therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab | Experimental | Drug: PanitumumabSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically confirmed diagnosis of metastatic carcinoid tumor and carcinoid syndrome
- Measurable disease as defined by RECIST criteria or evaluable disease
- All subjects must be 18 years of age or older.
- ECOG performance status of 0 to 2.
- Subjects may have had past or may be receiving current treatment with octreotide.
Key exclusion criteria (11 listed)
- Evidence of localized carcinoid tumor amenable to surgical resection or chemoembolization.
- People who are asymptomatic from their carcinoid tumors.
- Past treatment with EGFR inhibitors including cetuximab and panitumumab.
- History of active malignancies requiring treatment in the past 5 years with the exception of resected basal cell carcinoma of the skin.
- History of interstitial pneumonitis or pulmonary fibrosis.
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 |
|---|---|---|
| PanitumumabAlso: Vectibix, ABX-EGFPanitumumab will be given by intravenous infusion at a dose of 9 mg/kg on day 1 of study and then every 3 weeks until progression of disease | Drug | Panitumumab |
Primary outcome
Radiographic measures
Time frame: Every 4 cycles
Tumor Marker Evaluations
Time frame: Every 2 cycles
1 secondary outcome
Quality of LIfe
Time frame: Day 1 each cycle and 1 month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
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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.
Kevan Hartshorn, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab in people with Carcinoid Syndrome, run by Boston Medical Center at 2 sites 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 20 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: withdrawn, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Radiographic measures (time frame: Every 4 cycles). The study lists 2 primary outcomes in all. 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 26 Jul 2013.