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A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY 43-9006 (Sorafenib) in Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY 43-9006 (Sorafenib) in Metastatic Renal Cell Carcinoma


I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities
of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and
peri/postoperative safety of BAY 43-9006.


I. Time to progression. II. Duration of response. II. Overall Survival.


I. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR,
ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, P27, Ki67,
TGF-alpha, and TUNEL pre- and post- therapy (optional studies).

II. Oligonucleotide analysis of tissue pre- and post-therapy (optional studies).

OUTLINE: This is a non-randomized study. Patients are sequentially assigned to 1 of 3
treatment groups.

GROUP I: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral
sorafenib twice daily on days 15-84.

GROUP II: Patients receive oral sorafenib twice daily on days 1-7. Patients undergo
cytoreductive nephrectomy on day 8. Patients then receive oral sorafenib twice daily on days

GROUP III: Patients receive oral sorafenib twice daily on days 1-28. Patients undergo
cytoreductive nephrectomy on day 29. Patients then receive oral sorafenib twice daily on
days 43-84.

In all groups, patients with stable or regressing disease continue to receive oral sorafenib
twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Some patients may continue treatment for longer than 1 year at the discretion of the

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 45 patients (15 per treatment group) will be accrued for this
study within 1 year.

Inclusion Criteria:

- Patients with histologically or cytologically confirmed metastatic clear cell RCC who
are eligible for cytoreductive nephrectomy as agreed upon by Medical Oncology and
Urology team members; patients with metastatic disease eligible for cytoreductive
nephrectomy should have the following characteristics: resectable primary tumor (no
gross adjacent organ invasion, no or minimal abdominal lymphadenopathy, no or minimal
inferior vena caval involvement), bulk of metastatic disease within the primary
tumor, absence of multiple liver metastases, no more than 2 organ sites involved with

- Patients must have measurable disease, defined as a lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded) and measures >=
20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT)

- ECOG performance status =< 1

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Hgb > 9.0 g/dL

- Total bilirubin =< 2.0 mg/dl

- Albumin > 3.0 g/dL

- Serum creatinine =< 2.0 mg/dl

- AST (SGOT) and/or ALT (SGPT) =< 2.5 x institutional upper limit of normal for
subjects without evidence of liver metastases

- AST (SGOT) and/or ALT (SGPT) =< 5 X institutional upper limit of normal for subjects
with documented liver metastases

- Female patients of childbearing potential must have a normal plasma beta human
chorionic gonadotropin (beta-HCG) within 24 hours prior to enrolling in the study due
to the possible teratogenic effect; however, patients will be eligible if their
beta-HCG is elevated and is determined to be due to malignancy

- Patients of child fathering or childbearing potential must agree to practice a form
of medically acceptable birth control while on study

- 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 able to fully understand the investigational
nature of the study and the risks associated with the therapy

- Patients must have ability to comply with study and/or follow-up procedures

- Prior biopsy material (blocks or unstained slides) must be available for comparison

Exclusion Criteria:

- 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 5 years

- Patients must not have received any systemic anticancer therapy or radiotherapy
within 4 weeks prior to entering the study or those who have not recovered from
adverse events due to agents administered more than 4 weeks earlier

- Patients must not be scheduled to receive another experimental drug while on this
study; patients are permitted to be on concomitant bisphosphonates

- Patients who are incapable of swallowing pills are excluded from this study

- Patients must not have a primary brain tumor, any brain metastases, leptomeningeal
disease, seizure disorders not controlled with standard medical therapy, or history
of stroke

- Patients must not have active acute infections that could be worsened by anticancer
therapy or interfere with this study

- Patients must not have clinically significant cardiovascular disease, recent
myocardial infarction (i.e. last 6 months), (unstable angina), New York Heart
Association (NYHA) grade II or greater congestive heart failure, serious cardiac
dysrhythmia requiring medication, or peripheral vascular disease (grade II or

- 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 an investigational drug or that
might affect the interpretation of the results of the study or render the subject at
high risk from treatment complications

- Patients with uncontrolled hypertension > 140/90 are excluded from the study

- Patients must not have any history of bleeding diathesis; patients must not be on
therapeutic anticoagulation; prophylactic anticoagulation (i.e. low dose coumadin) of
venous or arterial access devices is allowed provided that the requirements for PT,
INR or PTT are met

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with BAY 43-9006

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of BAY 43-9006 by Evaluating Response Rate

Outcome Description:

Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.

Outcome Time Frame:

Every 2 weeks during 4 week cycle

Safety Issue:


Principal Investigator

Eric Jonasch

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



M D Anderson Cancer Center Houston, Texas  77030