AzTrials
AzTrials

Adenocarcinoma of the PancreasPhase 2NCT00075647

CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer 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
40 participants
Where
1 siteUnited States
Study dates
Dec 2003to Mar 2005
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 adenocarcinoma of the pancreas
  • Locally advanced or metastatic disease
  • Radiographic evidence of disease
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
Show all 35Show fewer
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Fasting serum cholesterol ≤ 350 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • No prior chemotherapy for metastatic pancreatic cancer
  • More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
  • Must have radiographic evidence of recurrent disease
  • More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
  • Must have radiographic evidence of disease progression
  • See Chemotherapy
  • See Chemotherapy
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.

SECONDARY OBJECTIVES:

  1. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.

II. Correlate biomarkers of response with clinical response in patients treated with this drug.

III. Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

Being tested
temsirolimus, laboratory biomarker analysis
Medical subject headings
Pancreatic Neoplasms

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 NCT00075647
Study groupRoleWhat they receive
Treatment (temsirolimus)ExperimentalPatients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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. Overall survival (OS)

    The method of Thall and Simon will be employed.

    Measured: 6 months

Secondary outcomes (6)

  1. Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated

    95% confidence interval will be presented

    Measured: Up to 2 years

  2. Duration of response

    Measured: From the time of objective response to the time of progressive disease, assessed up to 2 years

  3. Time to progression (TTP)

    Measured: From the time of the study entry to the time of relapse or progression, assessed up to 2 years

  4. Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

    Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.

    Measured: Up to 2 years

  5. Levels of PTEN, AKT, and PI3K

    Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis

    Measured: Up to 2 years

  6. Expression and phosphorylation status of p70s6k

    Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.

    Measured: Up to 7 days

Timeline

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

  1. First posted12 Jan 2004 (estimated)
  2. Study startDec 2003
  3. Primary completionMar 2005

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075647
Sponsor's protocol ID
NCI-2012-02567
Other IDs
MDA-2003-0530, N01CM17003, CDR0000347405
Status last verified
Jan 2013
First submitted
9 Jan 2004
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI) 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 35 inclusion and 0 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 17 Jan 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.

What does the primary outcome measure?

Overall survival (OS) (time frame: 6 months). 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 NCT00075647.

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 17 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in