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Metastatic Gastrointestinal Carcinoid TumorPhase 2NCT00093782

Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Metastatic Gastrointestinal Carcinoid Tumor and Pulmonary Carcinoid Tumor, run by National Cancer Institute (NCI) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
temsirolimus and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
Dec 2003to Apr 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 must have histologically or cytologically confirmed neuroendocrine tumours either of carcinoid histology or a carcinoma of pancreatic islet cell origin; small cell variant, endocrine organ carcinomas, and adrenal gland malignancies (including paragangliomas) are excluded from this study
  • Patients must have progressive metastatic disease defined by one of the following occurring within 6 months of study entry:
  • At least a 25% increase in radiologically or clinically measurable disease
  • Appearance of any new lesion or
  • Deterioration in clinical status
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
Show all 23Show fewer
  • Previous local therapy (e.g. chemoembolization or bland embolization) allowed if completed > 6 weeks prior to study entry; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
  • Previous chemotherapy, investigational agents or radioactive therapies (e.g. radioactive octreotide) allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained BCNU or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease prior to study entry
  • Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry
  • Previous radiation therapy is allowed if > 4 weeks have elapsed since delivery of a dose likely to have myelotoxic effects (e.g. ≥ 3000cGy to fields including substantial marrow)
  • Life expectancy of greater than 3 months
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  • Leukocytes ≥ 3.0 x 10^9/L
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Total bilirubin ≤ 1.25 x ULN
  • AST(SGOT)/ALT(SGPT) ≤ 3 x ULN; < 5 x ULN with liver metastases
  • Creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) calculated ≥ 60mL/min/1.73m^2
  • Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
  • Triglycerides =< 400 mg/dL (4.56 mmol/L)
  • Must be willing and able to undergo tumor biopsy once before and once during experimental therapy; patients must have tumor lesions accessible for biopsy for correlative studies; in cases where there is a medical contraindication to tumor biopsy, exception may be granted upon discussion with the Principal Investigator/Chair
  • The effects of CCI-779 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents concurrently or within 4 weeks of study entry
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
  • Concurrent cancer from another primary site requiring treatment of any kind within the past 3 years; curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix are allowed
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because CCI-779 is an inhibitor of mRNA translation with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CCI-779, breastfeeding should be discontinued if the mother is treated with CCI-779
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with CCI-779; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital Phase 2 Consortium

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas

This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

OBJECTIVES:

  1. To assess the objective tumor response rate (i.e. partial or complete responses as defined by the RECIST criteria) in patients with progressive metastatic neuroendocrine tumours given CCI-779.

II. To assess the stable disease rate and duration, time to progression, median survival time, 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779. As of 19 July 2010, overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up. At that point in time, these patients had been off-treatment for 3 to 5 years. Time to progression and median survival times will be based on the currently available data.

III. To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin (mTOR). Where post-treatment biopsies are available, they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression, apoptosis or anti-angiogenic effects.

OUTLINE: This is an open-label, multicenter study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.

Patients are followed up for survival.

Being tested
temsirolimus, laboratory biomarker analysis
Medical subject headings
Carcinoma, Islet Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00093782
Study groupRoleWhat they receive
Treatment (temsirolimus)ExperimentalPatients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
Receives: Drug: temsirolimus; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 8 years

Secondary outcomes (6)

  1. Stable Disease Rate Defined by RECIST Criteria

    Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

    Measured: Up to 8 years

  2. Median Survival Time

    Computed using the Kaplan-Meier method.

    Measured: 3

  3. Survival Rate

    Computed using the Kaplan-Meier method.

    Measured: 1 year

  4. Response and Stable Disease

    Assessed using RECIST criteria.Patients that had Stable disease for 2 months

    Measured: 2 months

  5. Number of Temsirolimus Treatment Cycle Analyzed for Toxicity

    Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3

    Measured: Duration of participants treatment upto 16wks (4cycles) of treatment

  6. Time to Progression

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study startDec 2003
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093782
Sponsor's protocol ID
NCI-2012-03053
Other IDs
PHL-021, 6171, N01CM17105, N01CM17107, N01CM17102
Status last verified
Dec 2016
First submitted
6 Oct 2004
Last updated
7 Feb 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Metastatic Gastrointestinal Carcinoid Tumor and Pulmonary Carcinoid Tumor, run by National Cancer Institute (NCI) at 1 site in Canada.

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 23 inclusion and 8 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 7 Feb 2017. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria) (time frame: Up to 8 years). 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 NCT00093782.

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 7 Feb 2017.

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