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AzTrials

Cervical CancerPhase 1NCT00967928

Everolimus Dose Finding Study for Stage IV or Recurrent Cervical Cancer

A Phase 1 study testing RAD001, Cisplatin and External Beam Whole Pelvis Radiation Therapy in people with Cervical Cancer, run by Accelerated Community Oncology Research Network.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This Phase 1, single-site, dose-escalation study is being conducted to determine the maximum tolerated dose (MTD) of RAD001 as part of a specified combination regimen. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
RAD001, Cisplatin and External Beam Whole Pelvis Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2009to Dec 2010
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors criteria that has not been previously irradiated.
  • Female patient aged ≥18 years.
  • Patient has life expectancy of at least 12 weeks at study start.
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study start.
  • Patient has diagnosis of stage IV or recurrent, non-resectable, cervical cancer at study start.
  • Patient has received no prior chemotherapy.
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  • Patient has adequate hematologic function:
  • Absolute neutrophil count [ANC] ≥1500/μL
  • Platelets ≥100,000/μL
  • Hemoglobin > 9g/dL
  • Patient has adequate renal function:
  • Serum creatinine ≤ 2.0 mg/dL
  • Calculated creatinine clearance ≥ 50 mL/min
  • Patient has adequate hepatic function:
  • Serum bilirubin ≤1.5 x ULN
  • ALT and AST ≤2.5 × ULN (≤ 5 x ULN in patients with liver metastases)
  • INR <1.5 (or < 3 on anticoagulants)
  • Patient has fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN.
  • Patient is able to provide signed informed consent.

Who cannot join

  • Patient has neuroendocrine or small cell carcinoma of the cervix.
  • Patient has previously used any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors.
  • Patient is currently receiving anticancer therapies or has received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.).
  • Patient has had a major surgery or significant traumatic injury within 4 weeks of start of study drug; patient has not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patient might require major surgery during the course of the study.
  • Patient has had prior treatment with any investigational drug within the preceding 4 weeks before study start.
  • Patient is receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
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  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Patients should also avoid close contact with people who have received live vaccines during treatment with everolimus. Examples of live vaccines are: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, and TY21a typhoid vaccines.
  • Patient has known brain or leptomeningeal metastases.
  • Patient has had other malignancies within the past 3 years except for adequately treated squamous cell carcinomas of the skin.
  • Patients has any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Symptomatic congestive heart failure of New York Heart Association Class III or IV.
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
  • Severely impaired lung function defined as spirometry and diffusing capacity (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air.
  • Uncontrolled diabetes as defined by fasting serum glucose >1.5 × ULN.
  • Active (acute or chronic) or uncontrolled severe infections.
  • Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • Patient has a known history of human immunodeficiency virus seropositivity.
  • Patient has impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
  • Patient has an active, bleeding diathesis.
  • Female patient who is pregnant or breast feeding, or an adult of reproductive potential who is not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial and for up to 8 weeks after ending treatment by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001.)
  • Patient has received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  • Patient has a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.
  • Patient has history of noncompliance to medical regimens.
  • Patient is unwilling to or unable to comply with the protocol.

About this study

Official title: Phase I Everolimus Dose Finding Study for the Treatment of Stage IV or Recurrent, Non-resectable, Cervical Cancer With Standard Whole Pelvic Radiation Therapy in Combination With Weekly Cisplatin and Daily Everolimus

This Phase 1, single-site, dose-escalation study is being conducted to determine the maximum tolerated dose (MTD) of RAD001 as part of a specified combination regimen.

Read the detailed description

This Phase 1, single-site, dose-escalation study is being conducted to determine the MTD of RAD001 as part of a specified combination regimen. The combination regimen will be standard field whole pelvic RT in combination with cisplatin at 40mg/m2 weekly with RAD001 at dose escalation daily starting at 5 mg qod, then 5 mg qd, then 10 mg qd during the period of whole pelvic radiation therapy.

Conditions
Cervical Cancer
Being tested
RAD001, Cisplatin, External Beam Whole Pelvis Radiation Therapy
Keywords
Stage IV or Recurrent Cervical cancer
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.

  • RAD001Drug

    Also called Afinitor, Everolimus

    RAD001 will be administered orally as 5 mg qod, 5 mg qd, or 10mg qd continuously from study Day 1 until the end of whole pelvic radiation therapy unless the patient develops progression of disease or unacceptable toxicity prior to that.

  • CisplatinDrug

    Also called CDDP, Platinol

    Cisplatin will be administered intravenously once weekly at 40mg/m2 for 6 weeks. The preferred administration day is Monday.

  • External Beam Whole Pelvis Radiation TherapyRadiation

    Patients will receive 180 cGy daily fraction Monday through Friday x 25 days (4500 cGy total) using a four field technique throughout the entire treatment with all fields treated each day.

Study groups in NCT00967928
Study groupRoleWhat they receive
Single armExperimentalAll subjects receive RAD001 in combination with standard field whole pelvic radiation and cisplatin.
Receives: Drug: RAD001; Drug: Cisplatin; Radiation: External Beam Whole Pelvis Radiation Therapy

What is being measured

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

  1. To determine the maximum tolerated dose for RAD001 as adjunct therapy to standard upfront treatment of advanced stage cervical cancer in combination with weekly cisplatin and whole pelvic external beam radiation

    Measured: every 7 days

  2. To determine the dose limiting toxicities for RAD001 as adjunct therapy to standard upfront treatment of advanced stage cervical cancer in combination with weekly cisplatin and whole pelvic external beam radiation

    Measured: every 7 days

Secondary outcomes (6)

  1. To determine the pharmacokinetics of RAD001 given as adjunct therapy to standard upfront treatment of advanced stage cervical cancer

    Measured: day 1 and day 15 during study treatment

  2. To evaluate the pharmacogenetics of RAD001 in the specified patient population

    Measured: day 1 prior to starting study treatment

  3. To evaluate microvessel density pre-and post-treatment with the specified treatment regimen in the specified patient population

    Measured: day 1 and end of treatment

  4. To evaluate potential correlations between biomarkers HIF-1a, TSP-1, P53, VEGF, and VEGFR and use of the specified treatment regimen in the specified patient population

    Measured: day 1 and end of treatment

  5. To evaluate progression free survival in the specified patient population

    Measured: from the time of treatment start until progression or up to 5 years after completion of study treatment

  6. To assess quality of life as indicated by the Patient Care Monitor in the specified patient population

    Measured: every 7 days during study treatment

Timeline

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

  1. First posted28 Aug 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Why it stopped: Lack of enrollment

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00967928
Sponsor's protocol ID
ATDTCC0801
Status last verified
Feb 2014
First submitted
27 Aug 2009
Last updated
14 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RAD001, Cisplatin and External Beam Whole Pelvis Radiation Therapy in people with Cervical Cancer, run by Accelerated Community Oncology Research Network.

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 19 inclusion and 24 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: withdrawn, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

To determine the maximum tolerated dose for RAD001 as adjunct therapy to standard upfront treatment of advanced stage cervical cancer in combination with weekly cisplatin and whole pelvic external beam radiation (time frame: every 7 days). The study lists 2 primary outcomes in all. 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 NCT00967928.

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 14 Feb 2014.

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