AzTrials
AzTrials

Gastrointestinal Stromal TumorPhase 2NCT00087074

CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor

A Phase 2 study testing temsirolimus and laboratory biomarker analysis in people with Gastrointestinal Stromal Tumor and Recurrent Adult Soft Tissue Sarcoma, 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

This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. 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
55 participants
Where
1 siteUnited States
Study dates
Jun 2004to Dec 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 cytologic confirmed soft tissue sarcoma
  • Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments
  • Absolute neutrophil count (ANC) >= 1,500/μL
  • Platelets (PLTS) >= 100,000/μL
  • Hgb >= 10.0 g/dL
  • Direct bilirubin =< 1.5 x ULN (upper limit normal)
Show all 15Show fewer
  • AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
  • ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
  • Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2
  • Baseline glucose levels
  • Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
  • Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)
  • ECOG Performance Status (PS) 0, 1 or 2
  • Life expectancy >= 12 weeks
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

Who cannot join

  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Breast-feeding women
  • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Any of the following:
  • Nitrosoureas or mitomycin =< 6 weeks prior to study entry
Show all 19Show fewer
  • Other chemotherapy =< 4 weeks prior to study entry
  • Radiotherapy =< 4 weeks prior to study entry
  • Concurrent use of any other investigation agent
  • Adverse events due to agents administered =< 4 weeks prior to study entry
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known HIV-positive patients receiving combination anti-retroviral therapy
  • Prior chemotherapy for metastatic disease
  • Exceptions:
  • Patients with GIST who fail Gleevec are eligible
  • Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible
  • Known brain metastases
  • Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.

This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. 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

PRIMARY OBJECTIVES:

  1. To assess the antitumor activity of CCI-779 in this patient population.

SECONDARY OBJECTIVES:

  1. To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779: duration of response, time to progression, survival.

TERTIARY OBJECTIVES:

  1. To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779: relative levels of 4EBP1 to eIF4E, phospho 4EBP1, total and phospho ribosomal S6 on pretreatment tumor tissue, expression levels of EGFR, activated EGFR, Her2, c-Myc, phospho Akt, total Akt, phospho-mTOR and total mTOR on pretreatment tumor tissue, drug induced inhibition of p70S6 kinase activity, and phosphorylation of S6 in PBMC, relative levels of serum sirolimus in post-treatment samples.

OUTLINE:

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Being tested
temsirolimus, laboratory biomarker analysis
Medical subject headings
Gastrointestinal Stromal Tumors, Sarcoma

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

    Optional correlative studies

Study groups in NCT00087074
Study groupRoleWhat they receive
Treatment (temsirolimus)ExperimentalPatients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
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. Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart

    Measured: Up to 6 months (6 courses)

Secondary outcomes (4)

  1. Survival time

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 5 years

  2. Time to disease progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to documentation of disease progression, assessed up to 5 years

  3. Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented

    Measured: Up to 5 years

  4. Time to treatment failure

    Measured: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years

Timeline

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

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087074
Sponsor's protocol ID
NCI-2012-02809
Other IDs
MC027B, N01CM17104
Status last verified
Jun 2013
First submitted
8 Jul 2004
Last updated
4 Jun 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 Gastrointestinal Stromal Tumor and Recurrent Adult Soft Tissue Sarcoma, 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 15 inclusion and 19 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 4 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.

What does the primary outcome measure?

Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart (time frame: Up to 6 months (6 courses)). 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 NCT00087074.

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 4 Jun 2013; AzTrials last refreshed its copy on 26 Oct 2026.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in