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Cervical AdenocarcinomaPhase 2NCT01026792

Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery

A Phase 2 study testing Temsirolimus and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, 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 studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. 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
38 participants
Where
1 siteCanada
Study dates
Dec 2009to Nov 2012
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 squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix
  • Patients must have unresectable, locally advanced or metastatic disease, incurable by standard therapies
  • Patients must have tumor tissue from their primary tumor available
  • Presence of clinically and/or radiologically documented disease
  • Chest x-ray >= 20 mm
  • Computed tomography (CT) scan (with slice thickness of =< 5 mm) >= 10 mm: longest diameter
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  • Physical exam (using calipers) >= 10 mm
  • Lymph nodes by CT scan >= 15 mm: measured in short axis
  • All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
  • Patients must have a life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Patients may have had up to one prior chemotherapy regimen; a minimum of 28 days (4 weeks) must have elapsed between the end of chemotherapy and study registration; Note: Radiotherapy with concurrent radiosensitizing cisplatin at the time of initial diagnosis and treatment is permitted, and is not considered systemic chemotherapy
  • Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; (exceptions may be made however, for low dose, palliative radiotherapy); patients must have recovered from any acute toxic effects from radiation prior to registration
  • Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration and that wound healing has occurred
  • Granulocytes (AGC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Serum creatinine =< 1.5 upper limit of normal (ULN)
  • Bilirubin =< 1.5 ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Fasting serum cholesterol =< 9.0 mmol/L
  • Fasting triglycerides =< 2.5 x ULN
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements; it will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) study coordinator that such clearance has been obtained, before the trial can commence in that center; a standard consent form for the trial will not be provided but a sample form is given; a copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the central office; the patient must sign the consent form prior to registration; please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records
  • Patients must be accessible for treatment, response assessment and follow-up; patients registered on this trial must be treated and followed at the participating center; this implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial; investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years
  • Patients must not have had prior treatment with an mTOR inhibitor
  • Pregnant or lactating women; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with temsirolimus; if the patient is of childbearing potential, a urine beta (β)-human chorionic gonadotropin (HCG) must be proved negative within 7 days prior to registration; women of child-bearing potential 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
  • Patients with known brain metastases (a brain CT is not necessary to rule out brain metastases, unless there is clinical suspicion of CNS involvement); patients with known brain metastases will be excluded from this trial
  • Patients with serious cardiovascular illness such as myocardial infarction within 6 months prior to entry, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia or uncontrolled hypertension
  • Patients who require use of therapeutic anticoagulation are ELIGIBLE but must have their prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) monitored closely during therapy
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus
  • Patients receiving concurrent treatment with other anti-cancer therapy or other investigational agents
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements
  • Active uncontrolled infection or non-healing wounds
  • Active peptic ulcer disease
  • Active bleeding or any other medical conditions that might be aggravated by treatment
  • Symptomatic congestive heart failure, unstable angina, cardiac arrhythmia
  • Fistula or history of fistula at any location, gastrointestinal (GI) perforation or abscess; patients believed to be at high risk for fistula formation because of the location and extent of their disease should not be enrolled

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • National Cancer Institute of Canada Clinical Trials Group

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix

This phase II trial studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.

II. To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.

III. To explore the relationship between expression of proteins in the mammalian target of rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their objective response to therapy.

OUTLINE:

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months (patients with complete response [CR], partial response [PR], or stable disease [SD] only) thereafter.

Being tested
Temsirolimus, Laboratory Biomarker Analysis
Medical subject headings
Uterine Cervical 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, Torisel

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01026792
Study groupRoleWhat they receive
Treatment (temsirolimus)ExperimentalPatients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses 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. Objective Response Rate

    Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1

    Measured: Up to 3 years

Timeline

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

  1. First posted4 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2012
  4. Study completionNov 2012

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026792
Sponsor's protocol ID
NCI-2014-00268
Other IDs
NCI-2014-00268, NCIC-CTG-199, CDR0000660702, IND.199, CAN-NCIC-IND199, NCIC-199, NCIC-199
Status last verified
Feb 2014
First submitted
3 Dec 2009
Last updated
10 Sep 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temsirolimus and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, 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 24 inclusion and 15 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 10 Sep 2015. 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 10 Sep 2015). 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 Response Rate (time frame: Up to 3 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 NCT01026792.

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 10 Sep 2015.

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