Neuroendocrine CarcinomaPhase 2NCT00193531
Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in High Grade Neuroendocrine Carcinoma
A Phase 2 study testing Paclitaxel, Carboplatin and Etoposide in people with Neuroendocrine Carcinoma, run by SCRI Development Innovations, LLC.
Trial summary
carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinoma
- What is being tested?
- Paclitaxel, Carboplatin and Etoposide
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 1998to Jan 2007
- 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
- To be included in this study, you must meet the following criteria:
- Metastatic poorly differentiated neuroendocrine carcinoma
- Unknown primary site
- Able to perform activities of daily living with minimal assistance
- Measurable or evaluable disease
- Adequate bone marrow, liver functions and kidney function
- No previous treatment with chemotherapy
- Understand the nature of this study and give written informed consent.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age < 18 years
- Previous malignancy within five years
- Women pregnant or lactating
- Recent history of cardiovascular disease
- Meningeal metastases
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Phase II Study of Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma
carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.
Read the detailed description
Upon determination of eligibility, patients will be receive:
- Paclitaxel + Carboplatin + Etoposide
- Conditions
- Neuroendocrine Carcinoma
- Being tested
- Paclitaxel, Carboplatin, Etoposide
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
CarboplatinDrug
EtoposideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Secondary outcomes (3)
Overall survival
Time to progression
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 1998
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193531
- Sponsor's protocol ID
- SCRI MISC 16
- Status last verified
- Apr 2023
- First submitted
- 12 Sep 2005
- Last updated
- 11 Apr 2023
- Results posted
- No
Publications
Hainsworth JD, Spigel DR, Litchy S, Greco FA. Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. J Clin Oncol. 2006 Aug 1;24(22):3548-54. doi: 10.1200/JCO.2005.05.0575.
PubMed 16877720
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT00193531
- Acronym / sponsor ID
- SCRI MISC 16
- Conditions
- Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Dec 1998
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Sep 2005 (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.
carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.
Detailed description
Upon determination of eligibility, patients will be receive:
- Paclitaxel + Carboplatin + Etoposide
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metastatic poorly differentiated neuroendocrine carcinoma
- Unknown primary site
- Able to perform activities of daily living with minimal assistance
- Measurable or evaluable disease
- Adequate bone marrow, liver functions and kidney function
Key exclusion criteria (7 listed)
- Age < 18 years
- Previous malignancy within five years
- Women pregnant or lactating
- Recent history of cardiovascular disease
- Meningeal metastases
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 |
|---|---|---|
| Paclitaxel | Drug | – |
| Carboplatin | Drug | – |
| Etoposide | Drug | – |
Primary outcome
Overall response
3 secondary outcomes
Overall survival
Time to progression
Overall toxicity
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 11 Apr 2023.
- Results publication: PubMed 16877720Hainsworth JD, Spigel DR, Litchy S, Greco FA. Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. J Clin Oncol. 2006 Aug 1;24(22):3548-54. doi: 10.1200/JCO.2005.05.0575.
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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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Carboplatin and Etoposide in people with Neuroendocrine Carcinoma, run by SCRI Development Innovations, LLC.
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 8 inclusion and 7 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 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193531, which also lists 1 linked publication.
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 11 Apr 2023.