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Renal Cell CarcinomaPhase 1/25-AZNCT00934440

A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

A Phase 1/2 study testing Bevacizumab and Azacitidine in people with Renal Cell Carcinoma, run by University of Kansas Medical Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Bevacizumab and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
Jun 2009to Nov 2015
Phase
Phase 1/2
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

  • Age > 18 years old
  • ECOG Performance Status 0, 1 or 2
  • Adequate bone marrow, liver and renal function as assessed by the following:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count(ANC)>1,500/mm3
  • Platelet count >100,000/mm3
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  • Total bilirubin < 1.5 times ULN
  • ALT and AST < 2.5 times the ULN (< 5 x ULN for patients with liver involvement)
  • Creatinine < 1.5 times ULN
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment.
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for duration of study. Men should use adequate birth control for at least 3 months after the last administration of Bevacizumab.
  • Ability to understand and willingness to sign written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • Patients not on anticoagulation must have an INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of treatment and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
  • Must have histologically or cytologically confirmed renal cell carcinoma which is metastatic (M1). Patients with unresectable primary tumors (but MO) are eligible.
  • Must have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension. Soft tissue disease that has been radiated in the 2 months prior to registration is not assessable as measurable disease. Soft tissue disease within a prior radiation field must have progressed to be considered assessable. X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration. X-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration.
  • Patients with metastatic disease who have a resectable primary tumor and deemed a surgical candidate may have undergone resection and have recovered from surgery. At least 28 days must have elapsed since surgery and must have recovered from any adverse effects of surgery.
  • Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000mg for patient enrollment. The urine protein used to calculate the UPC ratio must be obtained within 28 days prior to registration. NOTE: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1gm. UPC ratio is calculated using one of the following formulas: [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL
  • May have received prior immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or the combination of IFN/IL2 or prior chemotherapy (ie, gemcitabine and capecitabine).
  • Must have failed at least 1 prior biologic agent (sunitinib, sorafenib, or temsorlimus). No limit on the number of prior therapies.
  • At least 14 days must have elapsed since the last treatment. Must have recovered from any adverse effects of prior therapy.
  • May have received prior radiation therapy. At least 21 days must have elapsed since completion of prior radiation therapy. Must have recovered from all associated toxicities at the time of registration.
  • Pregnant or nursing women not eligible because of potential teratogenic side effects of 5-azacitidine and bevacizumab on the developing fetus or nursing infant. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-azacitidine or bevacizumab are not eligible.
  • Involvement in correlative studies must be offered to all patients but is not required.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which patient is currently in complete remission, or any other cancer from which patient has been disease-free for 2 years.
  • Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Who cannot join

  • Cardiac disease: Congestive heart failure > class II NYHA. Must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of brain to exclude brain metastasis.
  • Patients who have received prior bevacizumab are eligible for phase I portion of study but ineligible for phase II study.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
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  • Active clinically serious infection > CTCAE Grade 2.
  • Thrombosis or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. Patients with tumor related IVC thrombosis are eligible.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Stormont-Vail Cotton O'Neil Cancer Center

    Topeka, Kansas, 66606

Other trials in United States

About this study

Official title: A Phase I/II Study Evaluating The Efficacy OF 5-Azacitidine And Bevacizumab In Advanced Renal Cell Carcinoma

To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.

Read the detailed description

In this study, the investigator will assess progression-free and overall survival of patients with advanced renal cell carcinoma treated with 5-azacitidine in combination with bevacizumab. Patients will continue on treatment until either disease progression or development of other criteria for withdrawal.

Keywords
kidney cancer, renal cell
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    • First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes.
    • Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes.
    • Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles).

  • AzacitidineDrug

    Also called Vidaza

    • Dose level 1: 35 mg/m2/day for 7 days.
    • Dose level 2: 55 mg/m2/day for 7 days.
    • Dose level 3: 75 mg/m2/day for 7 days.
    • mg/m2/day = dose based on height and weight
Study groups in NCT00934440
Study groupRoleWhat they receive
Dose Escalation: 5-azacitidineExperimentalA traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.
Receives: Drug: Bevacizumab; Drug: Azacitidine

What is being measured

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

  1. Toxicities by Dose Level

    Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

    Measured: 3 to 6 months

Secondary outcomes (1)

  1. Time to Progression

    The time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.

    Measured: 2 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 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionNov 2015
  4. Study completionNov 2015

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 1/2
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00934440
Sponsor's protocol ID
11570
Acronym
5-AZ
Status last verified
May 2017
First submitted
23 Jun 2009
Last updated
14 Jun 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevacizumab and Azacitidine in people with Renal Cell Carcinoma, run by University of Kansas Medical Center at 2 sites 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 26 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

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 14 Jun 2017). 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?

Toxicities by Dose Level (time frame: 3 to 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 NCT00934440.

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 Jun 2017.

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