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

Phase 2
Open (Enrolling)
Renal Cell Cancer, Kidney Cancer

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Trial Information

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

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 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

Inclusion Criteria:

1. 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 FNA or
core biopsy of any metastatic site are eligible.

2. Patients must have measurable disease.

3. ECOG performance status 0-1.

4. 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/microL,
platelets >/= 100,000/microL, total bilirubin (SGPT) be dialysis).

5. Patients must have recovered from any effects of surgery.

6. 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.

7. 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.).

8. 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

9. Patients with brain metastases may participate in this trial.

10. 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.

Exclusion Criteria:

1. 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.

2. Pregnant or lactating women are excluded.

3. 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 ASCO guidelines.

4. 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.

5. 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), QTc interval > 500msec or other significant ECG
abnormalities or uncontrolled DM.

6. 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.

7. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
and indapamide) is not recommended.

8. Patients unwilling to participate or unable to comply with the protocol for the
duration of the study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Activity [Response rate + Progression free survival (PFS)]

Outcome Time Frame:

Day 1 of each 6 week cycle, 12 week evaulation

Safety Issue:


Principal Investigator

Nizar M. Tannir, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Renal Cell Cancer
  • Kidney Cancer
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030