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Metastatic Renal Cell CarcinomaPhase 1NCT00421512

A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients

A Phase 1 study testing Bevacizumab and Sunitinib in people with Metastatic Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering Cancer Center 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
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Trial summary

The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer. The drugs act to stop blood vessel growth but in different ways. They have not been studied together in a previous study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab and Sunitinib
Type of treatment
Pill or oral medicine
How many people
28 participants
Where
1 siteUnited States
Study dates
Mar 2006to May 2008
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed renal cell carcinoma (of any histological subtype) and with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present.
  • Evidence of unidimensionally measurable disease (i.e., greater than or equal to 1 malignant tumor mass that can be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional computerized tomography [CT] or magnetic resonance imaging [MRI], or greater than or equal to 10 mm with spiral CT scan [if spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used, e.g., if reconstruction size is 7 mm, lesion size should be greater than or equal to 14 mm]).
  • Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
  • Male or female, 18 years of age or older.
  • ECOG performance status 0 or 1.
  • Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1.
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  • Adequate organ function as defined by the following criteria:
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 1.5 x upper limit of normal (ULN)
  • Total serum bilirubin less than or equal to 1.5 mg/dL
  • Total white blood cell count greater than or equal to 3000 cells/µL
  • Absolute neutrophil count (ANC) greater than or equal to 1500/µL
  • Platelets greater than or equal to 100,000/µL
  • Hemoglobin greater than or equal to 9.0 g/dL
  • Serum calcium less than or equal to 12.0 mg/dL
  • Serum creatinine less than or equal to 2.0 x ULN
  • PT less than or equal to 1.5 ULN
  • Urine protein:creatinine ratio less than or equal to 1.0 at screening
  • Negative pregnancy test (only in women of childbearing age)
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Patients eligible for the higher priority IRB protocol #07-066
  • Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  • More than 2 prior systemic therapies for metastatic RCC.
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • NCI CTCAE grade 3 hemorrhage within the past 1 month.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
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  • History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis.
  • Any of the following within the 12 months prior to study drug administration:
  • severe/unstable angina, MI, CABG, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or peripheral vascular disease.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males and >470 msec for females.
  • Blood pressure > 150/90mmHg
  • Evidence of bleeding diathesis or coagulopathy
  • Serious, non-healing wound, ulcer or bone fracture
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Current treatment on another therapeutic clinical trial.
  • Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Receipt of any investigational agent within 4 weeks prior to study entry.
  • History of severe hypersensitivity reaction to bevacizumab or to any other component of bevacizumab.
  • Prior treatment with sunitinib, bevacizumab
  • Prior sorafenib given less than 8 weeks prior to study entry.
  • Unresolved symptoms or signs related to sorafenib within 8 weeks prior to study entry.
  • Use of therapeutic doses of coumadin.
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center 1275 York Avenue

    New York, New York, 10021

Other trials in United States

About this study

The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer. The drugs act to stop blood vessel growth but in different ways. They have not been studied together in a previous study. We also want to find out what effects (good and bad) the combination of bevacizumab and sunitinib have on you and your tumor.

Read the detailed description

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib administered in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma.

To assess antitumor activity of the combination of sunitinib and bevacizumab. To evaluate serum levels of vascular endothelial growth factor (VEGF) in patients treated with sunitinib and bevacizumab.

Study Design: This is a single center, open-label, Phase 1 study of sunitinib in combination with bevacizumab in patients with advanced metastatic renal cell carcinoma. This study is designed to confirm that the two agents can be administered safely in combination. Patients will begin treatment with bevacizumab on Day 0 and sunitinib on Day 1. Bevacizumab will be administered intravenously every two weeks. Sunitinib will be given orally on a 4 weeks on, 2 weeks off schedule. DLT determination will be based on toxicities observed in Cycles 1 - a cycle is defined by sunitinib dosing (6 weeks). Once the MTD for the combination has been identified, 10 additional patients will be enrolled at the MTD to further assess safety and efficacy. Patients will be treated with bevacizumab and sunitinib until there is disease progression, significant toxicity or withdrawal of patient consent. The maximum treatment duration is 24 months.

Being tested
Bevacizumab and Sunitinib
Keywords
Renal cell carcinoma, Metastatic, Kidney Cancer, Bevacizumab, Sunitinib
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Bevacizumab and SunitinibDrug

    On Cycle 1, Day 0, patients will begin treatment with bevacizumab. Sunitinib will begin on Day 1. The starting dose for sunitinib will be 25mg orally daily. sunitinib will be given in a four weeks on-two weeks off schedule. Bevacizumab will begin on Day 0 and will be administered every two weeks at 10mg/kg. A cycle of therapy is 6 weeks. The sunitinib dose escalation portion of the trial will be performed to determine the MTD of sunitinib given in combination with bevacizumab. Once the MTD has been determined, 10 additional patients will be treated at the MTD of sunitinib in combination with bevacizumab.

What is being measured

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

  1. To assess the maximum tolerated dose and overall safety and tolerability of sunitinib administered in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma.

    Measured: DLT determination will be based on toxicities observed in Cycles 1

Secondary outcomes (2)

  1. To assess antitumor activity of the combination of sunitinib and bevacizumab.

    Measured: 28 days +/- 3

  2. To evaluate serum levels of vascular endothelial growth factor (VEGF)

    Measured: every 28 days of a cycle +/- 3 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 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionMay 2008
  4. Study completionMay 2008

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421512
Sponsor's protocol ID
06-016
Status last verified
Nov 2008
First submitted
10 Jan 2007
Last updated
11 Nov 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab and Sunitinib in people with Metastatic Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering Cancer Center 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 20 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: finished, as of the sponsor's last update on 11 Nov 2008. 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 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 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?

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib administered in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma. (time frame: DLT determination will be based on toxicities observed in Cycles 1). 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 NCT00421512.

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 11 Nov 2008.

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