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Renal Cell CancerPhase 2NCT00465179

Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

A Phase 2 study testing Sunitinib Malate in people with Renal Cell Cancer and Kidney Cancer, run by M.D. Anderson 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 goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied. Read more about this study

Who is it for?
Any age
Conditions the study is for
Renal Cell Cancer, Kidney Cancer
What is being tested?
Sunitinib Malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
Mar 2007to Mar 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with conventional-type renal cell carcinoma who have >/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in fine-needle aspiration (FNA) or core biopsy of any metastatic site are eligible.
  • Patients must have measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/= 1,500/microliter (microL), platelets >/= 100,000/microL, total bilirubin </= 1.5 mg/dl, AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional uln, except in known hepatic metastasis, wherein may be </= 5 x uln, serum creatinine </= 4 X uln (as long as patient does not require dialysis).
  • Patients must have recovered from any effects of surgery.
  • Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.
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  • Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study (barrier method, hormonal methods, etc.).
  • Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.
  • Patients with brain metastases may participate in this trial.
  • Patients who have had up to two prior systemic therapies are eligible to participate in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such as sorafenib or sunitinib malate.

Who cannot join

  • No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
  • Pregnant or lactating women are excluded.
  • Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates. Patients are permitted to receive hematopoietic growth factors according to American Society of Clinical Oncology (ASCO) guidelines.
  • Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed at least 2 weeks prior to enrollment on this study.
  • Patients may not have any significant medical disease (other than the malignancy) that, in the investigator's opinion, would increase the risk for participation. Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias requiring medication (subjects with controlled chronic atrial fibrillation are eligible), myocardial infarction within 6 months, uncontrolled HTN (blood pressure >150/90 on therapy), corrected QT interval (QTc) interval > 500msec or other significant ECG abnormalities or uncontrolled DM.
  • Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
  • Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.
  • Patients unwilling to participate or unable to comply with the protocol for the duration of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma

The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.

Read the detailed description

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.

Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at your local doctor's office.

You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1.

At this visit, your medical history will be recorded, and your ability to perform daily activities will be evaluated. You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have experienced since your last visit. You will be asked about any medicines you may be currently taking. You will have blood drawn (about 4 teaspoons) for routine testing.

Beginning Day 1 of Cycle 3, you will return to clinic every 12 weeks (Day 1 of each cycle). You will have the same evaluations as you did at the Day 29 visit.

On Day 1 of every other cycle, you will have an ECG and a doppler echocardiogram or multigated acquisition (MUGA) scan to evaluate your heart health.

You will have follow-up imaging scans (CT and/or MRI) to track your response to treatment on Day 1 of the first 2 cycles and every 12 weeks thereafter for as long as you are receiving treatment on this study.

You will continue to receive treatment on this study, unless your disease gets worse, you develop an illness that prevents you from continuing treatment, or you experience any intolerable side effects of the study drug. You will be removed from this study if any of these circumstances occur.

This is an investigational study. Sunitinib malate has been authorized by the FDA for treatment of clear cell renal carcinoma. Its use in non-clear cell renal carcinoma is experimental. Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Being tested
Sunitinib Malate
Keywords
Non-Clear Cell Renal Carcinoma, Non-clear cell renal cell cancer, Renal Cell Cancer, Kidney Cancer, Papillary, Chromophobe, Collecting duct carcinoma, CDC, Renal medullary carcinoma, RMC, Sunitinib Malate, Sutent, SU011248
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.

  • Sunitinib MalateDrug

    Also called Sutent, SU011248

    50 mg by mouth daily for 4 weeks, then 2 weeks off.

Study groups in NCT00465179
Study groupRoleWhat they receive
Sunitinib MalateExperimentalSunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off.
Receives: Drug: Sunitinib Malate

What is being measured

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

  1. Number of Participants With Response to Treatment

    Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years

  2. Median Progression-Free Survival (PFS)

    Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.

    Measured: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years

Secondary outcomes (1)

  1. Median Overall Survival

    Overall survival was estimated using the Kaplan-Meier method.

    Measured: Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, 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 posted24 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionMar 2015
  4. Study completionMar 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00465179
Sponsor's protocol ID
2006-0437
Other IDs
NCI-2010-00583
Status last verified
May 2016
First submitted
20 Apr 2007
Last updated
7 Jun 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib Malate in people with Renal Cell Cancer and Kidney Cancer, run by M.D. Anderson 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 10 inclusion and 8 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 7 Jun 2016. 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?

Yes. Results are posted in the registry (first posted 4 May 2016). 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?

Number of Participants With Response to Treatment (time frame: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years). 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 NCT00465179.

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 7 Jun 2016.

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