Carcinoma of Unknown PrimaryPhase 2NCT00004922
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
A Phase 2 study testing irinotecan hydrochloride in people with Carcinoma of Unknown Primary and Neuroendocrine Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin
- What is being tested?
- irinotecan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Jun 2002
- 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
DISEASE CHARACTERISTICS:
- Histologically proven metastatic or unresectable high grade neuroendocrine tumor including:
- Small cell carcinoma
- Large cell neuroendocrine carcinoma
- Other high grade neuroendocrine carcinomas without specification to cell size
- No lung only involvement without any other primary site
- No primary small cell lung cancer with or without metastases
- Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm
- High grade tumor indicated by at least one of the following:
- Growth pattern suggestive of neuroendocrine differentiation
- Mitotic rate greater than 15 mitoses per 10 hpf
- Presence of abundant necrosis
- Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma
- No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT no greater than 5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No uncontrolled congestive heart failure requiring therapy
Other:
- No active or uncontrolled infection
- HIV negative
- No psychiatric or other disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 2 prior chemotherapy regimens
- No prior camptothecins
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
- Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.
- Conditions
- Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin
- Being tested
- irinotecan hydrochloride
- Keywords
- newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage III neuroendocrine carcinoma of the skin, recurrent neuroendocrine carcinoma of the skin, neuroendocrine carcinoma
- Medical subject headings
- Neoplasms, Unknown Primary, Carcinoma, Neuroendocrine, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2003 (estimated)
- Study startJun 1999
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Unknown PrimaryStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Sunil Sharma, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004922
- Sponsor's protocol ID
- 99-041
- Other IDs
- CDR0000067605, NCI-G00-1683
- Status last verified
- Jun 2013
- First submitted
- 7 Mar 2000
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00004922
- Acronym / sponsor ID
- 99-041
- Conditions
- Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin
- Keywords
- newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage III neuroendocrine carcinoma of the skin, recurrent neuroendocrine carcinoma of the skin, neuroendocrine carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1999
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 1 Oct 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors.
Detailed description
OBJECTIVES:
- Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
- Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| irinotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jun 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.
Sunil Sharma, MD study chair
Memorial Sloan Kettering Cancer 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 irinotecan hydrochloride in people with Carcinoma of Unknown Primary and Neuroendocrine Carcinoma, run by Memorial Sloan Kettering Cancer Center 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?
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 19 Jun 2013. 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.
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 19 Jun 2013.